Trial Outcomes & Findings for Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian, Epithelial, Primary Peritoneal, or Fallopian Tube Cancer (NCT NCT00565851)
NCT ID: NCT00565851
Last Updated: 2025-12-30
Results Overview
The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment. The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs \> 12 months). The median duration of follow-up is calculated by the reverse Kaplan-Meier method.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
1052 participants
Primary outcome timeframe
The time frame is 82.5 months (median duration of follow-up)
Results posted on
2025-12-30
Participant Flow
At the beginning of the study participants could be randomized to chemotherapy. On August 29, 2011 randomization to chemotherapy ended and participants could only be randomized to surgery.
Participant milestones
| Measure |
Arm I (no Surgery; Carboplatin and Paclitaxel)
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.
|
Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)
Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.
|
Arm III (Surgery; Carboplatin and Paclitaxel)
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
|
Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
|
Arm V (no Surgery; Carboplatin and Gemcitabine)
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
|
Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab)
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
|
Arm VII (Surgery; Carboplatin and Gemcitabine)
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
|
Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab)
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
|
|---|---|---|---|---|---|---|---|---|
|
Surgical Assignment
STARTED
|
316
|
456
|
33
|
165
|
6
|
34
|
5
|
37
|
|
Surgical Assignment
Randomized - Yes Surgery
|
0
|
0
|
33
|
165
|
0
|
0
|
5
|
37
|
|
Surgical Assignment
Randomized - no Surgery
|
33
|
172
|
0
|
0
|
6
|
34
|
0
|
0
|
|
Surgical Assignment
Not Surgical Candidate
|
283
|
284
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Surgical Assignment
COMPLETED
|
313
|
454
|
31
|
154
|
6
|
34
|
5
|
35
|
|
Surgical Assignment
NOT COMPLETED
|
3
|
2
|
2
|
11
|
0
|
0
|
0
|
2
|
|
Chemotherapy Assignment
STARTED
|
316
|
456
|
33
|
165
|
6
|
34
|
5
|
37
|
|
Chemotherapy Assignment
Randomized to Chemo
|
310
|
311
|
27
|
26
|
0
|
0
|
0
|
0
|
|
Chemotherapy Assignment
Pre-specified Chemo
|
6
|
145
|
6
|
139
|
6
|
34
|
5
|
37
|
|
Chemotherapy Assignment
COMPLETED
|
307
|
433
|
30
|
129
|
6
|
31
|
5
|
34
|
|
Chemotherapy Assignment
NOT COMPLETED
|
9
|
23
|
3
|
36
|
0
|
3
|
0
|
3
|
Reasons for withdrawal
| Measure |
Arm I (no Surgery; Carboplatin and Paclitaxel)
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.
|
Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)
Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.
|
Arm III (Surgery; Carboplatin and Paclitaxel)
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
|
Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
|
Arm V (no Surgery; Carboplatin and Gemcitabine)
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
|
Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab)
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
|
Arm VII (Surgery; Carboplatin and Gemcitabine)
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
|
Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab)
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
|
|---|---|---|---|---|---|---|---|---|
|
Chemotherapy Assignment
Never Initiated Chemotherapy
|
9
|
9
|
3
|
18
|
0
|
2
|
0
|
2
|
|
Chemotherapy Assignment
Still On Chemotherapy
|
0
|
14
|
0
|
18
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian, Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Baseline characteristics by cohort
| Measure |
Arm I (no Surgery; Carboplatin and Paclitaxel)
n=316 Participants
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.
Carboplatin: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)
n=456 Participants
Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.
Bevacizumab: Given IV
Carboplatin: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm III (Surgery; Carboplatin and Paclitaxel)
n=33 Participants
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)
n=165 Participants
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm V (no Surgery; Carboplatin and Gemcitabine)
n=6 Participants
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))
n=34 Participants
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VII (Surgery; Carboplatin and Gemcitabine)
n=5 Participants
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))
n=37 Participants
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Total
n=1052 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 10.0 • n=174 Participants
|
59.0 years
STANDARD_DEVIATION 10.3 • n=166 Participants
|
58.7 years
STANDARD_DEVIATION 10.0 • n=167 Participants
|
57.1 years
STANDARD_DEVIATION 10.5 • n=164 Participants
|
72.1 years
STANDARD_DEVIATION 7.4 • n=671 Participants
|
58.7 years
STANDARD_DEVIATION 8.2 • n=77 Participants
|
60.7 years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
61.1 years
STANDARD_DEVIATION 9.5 • n=18 Participants
|
59.4 years
STANDARD_DEVIATION 10.2
|
|
Age, Customized
< 40 years
|
4 Participants
n=174 Participants
|
14 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
7 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=18 Participants
|
25 Participants
|
|
Age, Customized
40 - 49 years
|
40 Participants
n=174 Participants
|
68 Participants
n=166 Participants
|
6 Participants
n=167 Participants
|
37 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
6 Participants
n=77 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=18 Participants
|
164 Participants
|
|
Age, Customized
50 - 59 years
|
102 Participants
n=174 Participants
|
170 Participants
n=166 Participants
|
11 Participants
n=167 Participants
|
57 Participants
n=164 Participants
|
1 Participants
n=671 Participants
|
14 Participants
n=77 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=18 Participants
|
365 Participants
|
|
Age, Customized
60 - 69 years
|
111 Participants
n=174 Participants
|
143 Participants
n=166 Participants
|
10 Participants
n=167 Participants
|
44 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
12 Participants
n=77 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=18 Participants
|
335 Participants
|
|
Age, Customized
70 - 79 years
|
52 Participants
n=174 Participants
|
54 Participants
n=166 Participants
|
6 Participants
n=167 Participants
|
19 Participants
n=164 Participants
|
5 Participants
n=671 Participants
|
2 Participants
n=77 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=18 Participants
|
148 Participants
|
|
Age, Customized
≥ 80 years
|
7 Participants
n=174 Participants
|
7 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
1 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=18 Participants
|
15 Participants
|
|
Sex: Female, Male
Female
|
316 Participants
n=174 Participants
|
456 Participants
n=166 Participants
|
33 Participants
n=167 Participants
|
165 Participants
n=164 Participants
|
6 Participants
n=671 Participants
|
34 Participants
n=77 Participants
|
5 Participants
n=4 Participants
|
37 Participants
n=18 Participants
|
1052 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=18 Participants
|
0 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=174 Participants
|
22 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
6 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=18 Participants
|
46 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
272 Participants
n=174 Participants
|
409 Participants
n=166 Participants
|
30 Participants
n=167 Participants
|
155 Participants
n=164 Participants
|
6 Participants
n=671 Participants
|
34 Participants
n=77 Participants
|
5 Participants
n=4 Participants
|
32 Participants
n=18 Participants
|
943 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
30 Participants
n=174 Participants
|
25 Participants
n=166 Participants
|
3 Participants
n=167 Participants
|
4 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=18 Participants
|
63 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=174 Participants
|
5 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=18 Participants
|
6 Participants
|
|
Race (NIH/OMB)
Asian
|
39 Participants
n=174 Participants
|
136 Participants
n=166 Participants
|
6 Participants
n=167 Participants
|
101 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
14 Participants
n=77 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=18 Participants
|
307 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=174 Participants
|
1 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=18 Participants
|
1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=174 Participants
|
17 Participants
n=166 Participants
|
1 Participants
n=167 Participants
|
4 Participants
n=164 Participants
|
1 Participants
n=671 Participants
|
3 Participants
n=77 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=18 Participants
|
44 Participants
|
|
Race (NIH/OMB)
White
|
255 Participants
n=174 Participants
|
294 Participants
n=166 Participants
|
26 Participants
n=167 Participants
|
57 Participants
n=164 Participants
|
5 Participants
n=671 Participants
|
17 Participants
n=77 Participants
|
3 Participants
n=4 Participants
|
25 Participants
n=18 Participants
|
682 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=18 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=174 Participants
|
3 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
3 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=18 Participants
|
12 Participants
|
|
Region of Enrollment
South Korea
|
20 Participants
n=174 Participants
|
108 Participants
n=166 Participants
|
4 Participants
n=167 Participants
|
90 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
11 Participants
n=77 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=18 Participants
|
242 Participants
|
|
Region of Enrollment
United States
|
284 Participants
n=174 Participants
|
324 Participants
n=166 Participants
|
29 Participants
n=167 Participants
|
67 Participants
n=164 Participants
|
6 Participants
n=671 Participants
|
23 Participants
n=77 Participants
|
5 Participants
n=4 Participants
|
28 Participants
n=18 Participants
|
766 Participants
|
|
Region of Enrollment
Japan
|
12 Participants
n=174 Participants
|
24 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
7 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=18 Participants
|
43 Participants
|
|
Region of Enrollment
Russia
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
1 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=18 Participants
|
1 Participants
|
|
Histology
Serous
|
252 Participants
n=174 Participants
|
383 Participants
n=166 Participants
|
30 Participants
n=167 Participants
|
142 Participants
n=164 Participants
|
5 Participants
n=671 Participants
|
30 Participants
n=77 Participants
|
4 Participants
n=4 Participants
|
35 Participants
n=18 Participants
|
881 Participants
|
|
Histology
Endometrioid
|
25 Participants
n=174 Participants
|
24 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
9 Participants
n=164 Participants
|
1 Participants
n=671 Participants
|
2 Participants
n=77 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=18 Participants
|
63 Participants
|
|
Histology
Clear Cell
|
13 Participants
n=174 Participants
|
14 Participants
n=166 Participants
|
1 Participants
n=167 Participants
|
5 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=18 Participants
|
33 Participants
|
|
Histology
Mucinous
|
2 Participants
n=174 Participants
|
2 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=18 Participants
|
4 Participants
|
|
Histology
Other
|
24 Participants
n=174 Participants
|
33 Participants
n=166 Participants
|
2 Participants
n=167 Participants
|
9 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
2 Participants
n=77 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=18 Participants
|
71 Participants
|
PRIMARY outcome
Timeframe: The time frame is 82.5 months (median duration of follow-up)Population: All patients who were eligible for the surgery analysis (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol)
The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment. The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs \> 12 months). The median duration of follow-up is calculated by the reverse Kaplan-Meier method.
Outcome measures
| Measure |
Paclitaxel and Carboplatin Chemotherapy With Bevacizumab
n=240 Participants
All patients who received paclitaxel and carboplatin chemotherapy with bevacizumab followed by bevacizumab maintenance therapy and were included in the chemotherapy analysis
|
Paclitaxel and Carboplatin Chemotherapy
n=245 Participants
All patients who received paclitaxel and carboplatin chemotherapy and were included in the chemotherapy analysis
|
Arm III (Surgery; Carboplatin and Paclitaxel)
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm V (no Surgery; Carboplatin and Gemcitabine)
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VII (Surgery; Carboplatin and Gemcitabine)
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|---|---|
|
To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer
|
50.6 Months
Interval 44.2 to 59.7
|
64.7 Months
Interval 54.5 to 73.9
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: The time frame is 82.5 months (median duration of follow-up).Population: All patients who were enrolled between December 10, 2007 and August 26, 2011 and received paclitaxel and carboplatin (with or without bevacizumab) (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol).
The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment. The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs \> 12 months). The median duration of follow-up is calculated by the reverse Kaplan-Meier method.
Outcome measures
| Measure |
Paclitaxel and Carboplatin Chemotherapy With Bevacizumab
n=337 Participants
All patients who received paclitaxel and carboplatin chemotherapy with bevacizumab followed by bevacizumab maintenance therapy and were included in the chemotherapy analysis
|
Paclitaxel and Carboplatin Chemotherapy
n=337 Participants
All patients who received paclitaxel and carboplatin chemotherapy and were included in the chemotherapy analysis
|
Arm III (Surgery; Carboplatin and Paclitaxel)
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm V (no Surgery; Carboplatin and Gemcitabine)
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VII (Surgery; Carboplatin and Gemcitabine)
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|---|---|
|
To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer
|
42.2 Months
Interval 37.7 to 46.2
|
37.3 Months
Interval 32.6 to 39.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Radiographic assessment of disease was conducted during chemotherapy and then every 6 months during the maintenance / surveillance phasePopulation: All patients who were enrolled and eligible for the chemotherapy analysis (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol).
Progression-free survival was defined as the time from randomization to cancer progression as shown on radiography, according to the RECIST version 1.0 criteria, an increase in the CA125 level according to Gynecologic Cancer InterGroup (GCIG) criteria, global deterioration of health, or death from any cause.
Outcome measures
| Measure |
Paclitaxel and Carboplatin Chemotherapy With Bevacizumab
n=337 Participants
All patients who received paclitaxel and carboplatin chemotherapy with bevacizumab followed by bevacizumab maintenance therapy and were included in the chemotherapy analysis
|
Paclitaxel and Carboplatin Chemotherapy
n=337 Participants
All patients who received paclitaxel and carboplatin chemotherapy and were included in the chemotherapy analysis
|
Arm III (Surgery; Carboplatin and Paclitaxel)
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm V (no Surgery; Carboplatin and Gemcitabine)
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VII (Surgery; Carboplatin and Gemcitabine)
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival (Chemotherapy Analysis)
|
13.8 Months
Interval 13.0 to 14.7
|
10.4 Months
Interval 9.7 to 11.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Radiographic assessment of disease (in patients with measurable and non-measurable disease) was conducted Every three months for two years and then every 6 months after completion of chemotherapy during the maintenance/surveillance phase.Population: All randomized patients who were eligible for the surgery analysis (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol).
Progression-free survival was defined as the time from randomization to cancer progression as shown on radiography, according to the RECIST version 1.0 criteria, an increase in the CA125 level according to Gynecologic Cancer InterGroup (GCIG) criteria, global deterioration of health, or death from any cause.
Outcome measures
| Measure |
Paclitaxel and Carboplatin Chemotherapy With Bevacizumab
n=240 Participants
All patients who received paclitaxel and carboplatin chemotherapy with bevacizumab followed by bevacizumab maintenance therapy and were included in the chemotherapy analysis
|
Paclitaxel and Carboplatin Chemotherapy
n=245 Participants
All patients who received paclitaxel and carboplatin chemotherapy and were included in the chemotherapy analysis
|
Arm III (Surgery; Carboplatin and Paclitaxel)
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm V (no Surgery; Carboplatin and Gemcitabine)
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VII (Surgery; Carboplatin and Gemcitabine)
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (Surgery Analysis)
|
18.9 Months
Interval 16.8 to 21.0
|
16.2 Months
Interval 14.2 to 19.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 monthsPopulation: Eligible and treated participants
Number of treated patients with at least one adverse event reported (assessed by Common Terminology Criteria for Adverse Events (version 4.0))
Outcome measures
| Measure |
Paclitaxel and Carboplatin Chemotherapy With Bevacizumab
n=456 Participants
All patients who received paclitaxel and carboplatin chemotherapy with bevacizumab followed by bevacizumab maintenance therapy and were included in the chemotherapy analysis
|
Paclitaxel and Carboplatin Chemotherapy
n=316 Participants
All patients who received paclitaxel and carboplatin chemotherapy and were included in the chemotherapy analysis
|
Arm III (Surgery; Carboplatin and Paclitaxel)
n=33 Participants
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)
n=165 Participants
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm V (no Surgery; Carboplatin and Gemcitabine)
n=6 Participants
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))
n=34 Participants
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VII (Surgery; Carboplatin and Gemcitabine)
n=5 Participants
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))
n=37 Participants
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|---|---|
|
Summary of Adverse Events (CTCAE Version 4.0)
|
376 Participants
|
304 Participants
|
29 Participants
|
77 Participants
|
3 Participants
|
9 Participants
|
3 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.Population: Provided baseline and at least one follow-up assessment (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol).
Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The FACT-O TOI score ranges 0-100 with a large score suggests better QOL.
Outcome measures
| Measure |
Paclitaxel and Carboplatin Chemotherapy With Bevacizumab
n=302 Participants
All patients who received paclitaxel and carboplatin chemotherapy with bevacizumab followed by bevacizumab maintenance therapy and were included in the chemotherapy analysis
|
Paclitaxel and Carboplatin Chemotherapy
n=298 Participants
All patients who received paclitaxel and carboplatin chemotherapy and were included in the chemotherapy analysis
|
Arm III (Surgery; Carboplatin and Paclitaxel)
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm V (no Surgery; Carboplatin and Gemcitabine)
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VII (Surgery; Carboplatin and Gemcitabine)
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|---|---|
|
Patient Reported Quality of Life (Chemotherapy Analysis)
Prior to cycle 3
|
73.4 score on a scale
Standard Error 0.9
|
74.2 score on a scale
Standard Error 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Quality of Life (Chemotherapy Analysis)
Prior to cycle 1 (baseline)
|
75.3 score on a scale
Standard Error 0.9
|
75.8 score on a scale
Standard Error 0.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Quality of Life (Chemotherapy Analysis)
Prior to cycle 6
|
72.3 score on a scale
Standard Error 1.0
|
73.3 score on a scale
Standard Error 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Quality of Life (Chemotherapy Analysis)
6 months post cycle 1
|
77.2 score on a scale
Standard Error 1.0
|
77.1 score on a scale
Standard Error 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Quality of Life (Chemotherapy Analysis)
12 months post cycle 1
|
77.8 score on a scale
Standard Error 1.0
|
77.0 score on a scale
Standard Error 1.1
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.Population: Provided baseline and at least one follow-up assessments (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol).
Patient reported physical functioning was measured with physical functioning subscale of the RAND SF-36. The Physical Functioning Subscale consists of 10 items concerning activities of daily living: walking, climbing stairs, bathing, dressing, and performance of physical activities. Each item is rated on a three-point scale of limitation of activity due to the patients' health from 1=limited a lot to 3=not limited. The total PF score is the summation of item scores and then rescaled to 0-100. A larger score suggests better physical functioning.
Outcome measures
| Measure |
Paclitaxel and Carboplatin Chemotherapy With Bevacizumab
n=302 Participants
All patients who received paclitaxel and carboplatin chemotherapy with bevacizumab followed by bevacizumab maintenance therapy and were included in the chemotherapy analysis
|
Paclitaxel and Carboplatin Chemotherapy
n=298 Participants
All patients who received paclitaxel and carboplatin chemotherapy and were included in the chemotherapy analysis
|
Arm III (Surgery; Carboplatin and Paclitaxel)
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm V (no Surgery; Carboplatin and Gemcitabine)
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VII (Surgery; Carboplatin and Gemcitabine)
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|---|---|
|
Patient Reported Physical Function (Chemotherapy Analysis)
6 months post cycle 1
|
70.2 score on a scale
Standard Error 2.1
|
71.6 score on a scale
Standard Error 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Physical Function (Chemotherapy Analysis)
Prior to cycle 1 (baseline)
|
69.4 score on a scale
Standard Error 1.7
|
71.5 score on a scale
Standard Error 1.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Physical Function (Chemotherapy Analysis)
Prior to cycle 3
|
69.8 score on a scale
Standard Error 2.1
|
73.2 score on a scale
Standard Error 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Physical Function (Chemotherapy Analysis)
Prior to cycle 6
|
64.6 score on a scale
Standard Error 2.2
|
71.5 score on a scale
Standard Error 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Physical Function (Chemotherapy Analysis)
12 months post cycle 1
|
70.7 score on a scale
Standard Error 2.2
|
71.8 score on a scale
Standard Error 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1. Prior to surgery, 2. 6 weeks post-surgery, 3. 15 weeks post-surgery, 4. 6 months post-surgery, 5. 12 months post-surgery.Population: Provided baseline and at least one follow-up assessment (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol).
Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The FACT-O TOI score ranges 0-100 with a large score suggests better QOL.
Outcome measures
| Measure |
Paclitaxel and Carboplatin Chemotherapy With Bevacizumab
n=206 Participants
All patients who received paclitaxel and carboplatin chemotherapy with bevacizumab followed by bevacizumab maintenance therapy and were included in the chemotherapy analysis
|
Paclitaxel and Carboplatin Chemotherapy
n=215 Participants
All patients who received paclitaxel and carboplatin chemotherapy and were included in the chemotherapy analysis
|
Arm III (Surgery; Carboplatin and Paclitaxel)
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm V (no Surgery; Carboplatin and Gemcitabine)
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VII (Surgery; Carboplatin and Gemcitabine)
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|---|---|
|
Patient Reported Quality of Life (Surgery Analysis)
15 weeks post-surgery
|
68.8 score on a scale
Standard Error 1.3
|
68.7 score on a scale
Standard Error 1.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Quality of Life (Surgery Analysis)
12 months post-surgery
|
75.6 score on a scale
Standard Error 1.3
|
74.0 score on a scale
Standard Error 1.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Quality of Life (Surgery Analysis)
Prior to surgery
|
74.2 score on a scale
Standard Error 1.0
|
74.5 score on a scale
Standard Error 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Quality of Life (Surgery Analysis)
6 weeks post-surgery
|
68.4 score on a scale
Standard Error 1.3
|
69.3 score on a scale
Standard Error 1.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Quality of Life (Surgery Analysis)
6 months post-surgery
|
73.5 score on a scale
Standard Error 1.3
|
72.6 score on a scale
Standard Error 1.3
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1. Prior to surgery (baseline), 2. 6 weeks post-surgery, 3. 15 weeks post-surgery 4. 6 months post-surgery, 5. 12 months post-surgeryPopulation: US patients who provided baseline and ≥ 1 follow-up assessments (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol).
Patient reported physical functioning was measured with physical functioning subscale of the RAND SF-36. The Physical Functioning subscale consists of 10 items concerning activities of daily living: walking, climbing stairs, bathing, dressing, and performance of physical activities. Each item is rated on a three-point scale of limitation of activity due to the patients' health from 1=limited a lot to 3=not limited. The total PF score is the summation of item scores and then rescaled to 0-100. A larger score suggests better physical functioning. This measure was completed by US patients only.
Outcome measures
| Measure |
Paclitaxel and Carboplatin Chemotherapy With Bevacizumab
n=113 Participants
All patients who received paclitaxel and carboplatin chemotherapy with bevacizumab followed by bevacizumab maintenance therapy and were included in the chemotherapy analysis
|
Paclitaxel and Carboplatin Chemotherapy
n=104 Participants
All patients who received paclitaxel and carboplatin chemotherapy and were included in the chemotherapy analysis
|
Arm III (Surgery; Carboplatin and Paclitaxel)
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm V (no Surgery; Carboplatin and Gemcitabine)
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab))
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VII (Surgery; Carboplatin and Gemcitabine)
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Bevacizumab: Given IV
Carboplatin: Given IV
Gemcitabine Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|---|---|---|---|
|
Patient Reported Physical Functioning (Surgery Analysis)
Prior to surgery (baseline)
|
71.7 score on a scale
Standard Error 2.3
|
73.4 score on a scale
Standard Error 2.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Physical Functioning (Surgery Analysis)
6 weeks post-surgery
|
69.8 score on a scale
Standard Error 2.1
|
73.2 score on a scale
Standard Error 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Physical Functioning (Surgery Analysis)
15 weeks post-surgery
|
64.6 score on a scale
Standard Error 2.2
|
71.5 score on a scale
Standard Error 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Physical Functioning (Surgery Analysis)
6 months post-surgery
|
70.2 score on a scale
Standard Error 2.1
|
71.6 score on a scale
Standard Error 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Physical Functioning (Surgery Analysis)
12 months post-surgery
|
70.7 score on a scale
Standard Error 2.2
|
71.8 score on a scale
Standard Error 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Arm I (no Surgery; Carboplatin and Paclitaxel)
Serious events: 37 serious events
Other events: 304 other events
Deaths: 253 deaths
Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)
Serious events: 104 serious events
Other events: 376 other events
Deaths: 299 deaths
Arm III (Surgery; Carboplatin and Paclitaxel)
Serious events: 1 serious events
Other events: 29 other events
Deaths: 28 deaths
Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)
Serious events: 24 serious events
Other events: 77 other events
Deaths: 56 deaths
Arm V (no Surgery; Carboplatin and Gemcitabine)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 4 deaths
Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 14 deaths
Arm VII (Surgery; Carboplatin and Gemcitabine)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 4 deaths
Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
Arm I (no Surgery; Carboplatin and Paclitaxel)
n=316 participants at risk
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.
|
Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)
n=456 participants at risk
Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.
|
Arm III (Surgery; Carboplatin and Paclitaxel)
n=33 participants at risk
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
|
Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)
n=165 participants at risk
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
|
Arm V (no Surgery; Carboplatin and Gemcitabine)
n=6 participants at risk
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
|
Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab)
n=34 participants at risk
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
|
Arm VII (Surgery; Carboplatin and Gemcitabine)
n=5 participants at risk
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
|
Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab)
n=37 participants at risk
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
|
|---|---|---|---|---|---|---|---|---|
|
Immune system disorders
Allergic Reaction/Hypersensitivity
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
8/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Blood and lymphatic system disorders
Myelodysplasia
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Blood and lymphatic system disorders
Neutrophils
|
0.95%
3/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.88%
4/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Blood and lymphatic system disorders
Platelets
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Blood and lymphatic system disorders
Leukocytes
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Cardiac disorders
S/N Arrhythmia: Atrial Fibrillation
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Cardiac disorders
Cardiac Ischemia/Infarction
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Cardiac disorders
Hypertension
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Cardiac disorders
Lt Ventricular Systolic Dysfunction
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Cardiac disorders
Hypotension
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Cardiac disorders
Cardipulmonary Arrest
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Death No Ctcae Term - Disease Progression Nos
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Death No Ctcae Term - Death Nos
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Death No Ctcae Term - Sudden Death
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Fistula, Gi - Colon/Cecum/Appendix
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Obstruction, Gi - Ileum
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Perforation, Gi - Colon
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Dental: Periodontal
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Fistula, Gi - Small Bowel Nos
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Obstruction, Gi - Colon
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Perforation, Gi - Cecum
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Ulcer,gi - Stomach
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Ileus
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.3%
6/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Perforation, Gi - Small Bowel Nos
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Vomiting
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Constipation
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Diarrhea
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Hemorrhage, Gi - Rectum
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Hemorrhage, Gi - Upper Gi Nos
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Hemorrhage/Pulmonary - Nose
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Hemorrhage, Gi - Stomach
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Hemorrhage, Cns
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas - Other
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Blood
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Foreign Body
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Soft Tissue Nos
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Blood
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Wound
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Febrile Neutropenia
|
2.2%
7/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.1%
14/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
3/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Infection - Other
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Pelvis Nos
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf Unknown Anc: Liver
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf Unknown Anc: Urinary Tract Nos
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf Unknown Anc: Foreign Body
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf Unknown Anc: Catheter-Related
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Foreign Body
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Upper Airway Nos
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Eye Nos
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Catheter-Related
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Cholesterol,serum High
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Alt
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/St: Other
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Right-Sided
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Syncope
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Neurology - Other
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Mood Alteration - Depression
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Cns Ischemia
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.88%
4/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Confusion
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Neuropathy-Sensory
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Neuropathy-Motor
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Eye disorders
Blurred Vision
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain - Other
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Chest /Thorax Nos
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Head/Headache
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Back
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Abdominal Pain Nos
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.1%
5/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
2nd Mal: Poss. Related To Cancer Rx
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Vascular - Other
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
1.3%
4/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.3%
6/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
Other adverse events
| Measure |
Arm I (no Surgery; Carboplatin and Paclitaxel)
n=316 participants at risk
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.
|
Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab)
n=456 participants at risk
Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.
|
Arm III (Surgery; Carboplatin and Paclitaxel)
n=33 participants at risk
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
|
Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab)
n=165 participants at risk
Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
|
Arm V (no Surgery; Carboplatin and Gemcitabine)
n=6 participants at risk
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
|
Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab)
n=34 participants at risk
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.
|
Arm VII (Surgery; Carboplatin and Gemcitabine)
n=5 participants at risk
Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
|
Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab)
n=37 participants at risk
Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
|
|---|---|---|---|---|---|---|---|---|
|
Immune system disorders
Allergy/Immunology - Other
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Immune system disorders
Allergic Reaction/Hypersensitivity
|
24.1%
76/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
18.9%
86/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
18.2%
6/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
9.7%
16/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
16.7%
1/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
8.1%
3/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Immune system disorders
Vasculitis
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Immune system disorders
Rhinitis
|
4.1%
13/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
13.6%
62/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.8%
8/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Immune system disorders
Autoimmune Reaction
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Ear and labyrinth disorders
Otitis Middle Ear
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Ear and labyrinth disorders
Auditory/Ear - Other
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Ear and labyrinth disorders
Hearing (Without Monitoring Program)
|
1.6%
5/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.6%
12/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Ear and labyrinth disorders
Tinnitus
|
4.7%
15/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.0%
23/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
16.7%
1/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Ear and labyrinth disorders
Hearing (Monitoring Program)
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Blood and lymphatic system disorders
Neutrophils
|
89.2%
282/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
79.6%
363/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
84.8%
28/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
43.6%
72/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
50.0%
3/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.6%
7/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
60.0%
3/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
21.6%
8/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Blood and lymphatic system disorders
Platelets
|
54.7%
173/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
57.9%
264/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
66.7%
22/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
31.5%
52/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
50.0%
3/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.6%
7/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
60.0%
3/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
21.6%
8/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Blood and lymphatic system disorders
Leukocytes
|
87.3%
276/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
76.8%
350/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
84.8%
28/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
40.6%
67/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
50.0%
3/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
26.5%
9/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
60.0%
3/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
24.3%
9/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.6%
21/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
6.8%
31/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Blood and lymphatic system disorders
Hemoglobin
|
88.3%
279/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
69.3%
316/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
87.9%
29/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
40.6%
67/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
50.0%
3/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
26.5%
9/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
60.0%
3/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
24.3%
9/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Cardiac disorders
Prolonged Qtc Interval
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Cardiac disorders
S/N Arrhythmia: Atrial Fibrillation
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Cardiac disorders
Palpitations
|
3.8%
12/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.2%
19/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.4%
4/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
16.7%
1/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Cardiac disorders
Cardiac Arrhythmia - Other
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Cardiac disorders
Ventricular Arrhythmia - Tachycardia
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Tachycardia
|
1.6%
5/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.3%
15/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Bradycardia
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Cardiac disorders
Ventricular Arrhythmia - Pvcs
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Cardiac disorders
Ventricular Arrhythmia - Fibrillation
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Cardiac disorders
Cardiac Ischemia/Infarction
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Cardiac disorders
Hypertension
|
3.2%
10/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
32.2%
147/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
13.3%
22/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
13.5%
5/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Cardiac disorders
Restrictive Cardiomyopathy
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Cardiac disorders
Left Venticular Diastolic Dysfunction
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Cardiac disorders
Cardiac General - Other
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Cardiac disorders
Cardiac Troponin I (Ctni)
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Cardiac disorders
Hypotension
|
0.95%
3/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.6%
12/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Cardiac disorders
Cardipulmonary Arrest
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Inr
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.0%
9/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Dic
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Thrombotic Microangiopathy
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Ptt
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.5%
7/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Constitutional Symptoms - Other
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.1%
5/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Sweating
|
3.2%
10/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
8/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
6.1%
2/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Weight Gain
|
5.7%
18/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.9%
27/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.6%
6/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Fever
|
9.8%
31/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
9.9%
45/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
7.9%
13/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Weight Loss
|
3.8%
12/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
11.8%
54/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.6%
6/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Rigors/Chills
|
2.2%
7/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.1%
14/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
3/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Fatigue
|
77.5%
245/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
65.1%
297/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
75.8%
25/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
29.1%
48/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
33.3%
2/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
14.7%
5/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
60.0%
3/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
13.5%
5/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Insomnia
|
14.9%
47/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
14.7%
67/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
12.1%
4/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
7.9%
13/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
8.1%
3/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
2.8%
9/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
8.6%
39/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
0.95%
3/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.0%
9/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (Scalp Or Body)
|
77.5%
245/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
63.4%
289/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
63.6%
21/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
28.5%
47/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
33.3%
2/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
8.8%
3/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.4%
2/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Skin and subcutaneous tissue disorders
Cheilitis
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Skin and subcutaneous tissue disorders
Wound Complication, Non-Infectious
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
8/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
6.1%
2/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Skin and subcutaneous tissue disorders
Bruising
|
3.5%
11/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.3%
15/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.0%
9/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.5%
49/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
19.1%
87/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
12.1%
4/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
6.1%
10/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
8.8%
3/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.4%
2/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
1.6%
5/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.5%
25/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
3/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Skin and subcutaneous tissue disorders
Decubitus
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.9%
25/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
10.1%
46/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
6.1%
2/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
6.1%
10/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Skin and subcutaneous tissue disorders
Burn
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.6%
5/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.0%
23/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Skin and subcutaneous tissue disorders
Flushing
|
3.5%
11/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.6%
21/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
3/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Skin and subcutaneous tissue disorders
Hand-Foot
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.1%
5/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
3/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
3.2%
10/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.0%
23/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
3/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.2%
10/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.0%
9/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Endocrine disorders
Hot Flashes
|
8.5%
27/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
9.9%
45/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
15.2%
5/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.8%
8/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.9%
2/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Endocrine disorders
Diabetes
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Endocrine disorders
Adh Secrection Abnormality
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Endocrine disorders
Hypoparathyroidism
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Endocrine disorders
Endocrine - Other
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Endocrine disorders
Hypothyroidism
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.88%
4/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Salivary Gland Changes
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Flatulence
|
1.6%
5/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.4%
11/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Ulcer,gi - Esophagus
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Perforation, Gi - Colon
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Dental: Periodontal
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.2%
10/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Fistula, Gi - Small Bowel Nos
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Fistula, Gi - Rectum
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Gastritis
|
1.3%
4/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.1%
5/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Esophagitis
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.88%
4/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Perforation, Gi - Cecum
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.8%
22/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Heartburn
|
8.9%
28/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
11.2%
51/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
9.1%
3/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.8%
8/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Esophagus
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Ulcer,gi - Stomach
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.1%
5/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Dental: Teeth
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.5%
7/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Trachea
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Ascites
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.88%
4/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Leak, Gi - Rectum
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Ileus
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Dysphagia
|
1.9%
6/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.4%
20/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Distention
|
5.7%
18/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.9%
27/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
9.1%
3/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.6%
6/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Taste Alteration
|
11.4%
36/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
10.1%
46/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
9.1%
3/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
6.1%
10/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Incontinence, Anal
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Dry Mouth
|
1.9%
6/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.7%
17/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Stomach
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Rectum
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Oral Cavity
|
10.1%
32/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
15.1%
69/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
6.1%
2/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.8%
8/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
0.95%
3/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.88%
4/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Fistula, Gi - Oral Cavity
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Perforation, Gi - Small Bowel Nos
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Oral Cavity
|
7.3%
23/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
14.7%
67/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
8.5%
14/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
11.8%
4/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Larynx
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Vomiting
|
23.7%
75/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
27.4%
125/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
21.2%
7/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
9.7%
16/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
10.8%
4/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Anorexia
|
24.7%
78/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
28.3%
129/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
30.3%
10/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
11.5%
19/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
8.8%
3/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Dehydration
|
3.8%
12/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.4%
20/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
5/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Constipation
|
52.8%
167/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
42.3%
193/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
60.6%
20/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
23.6%
39/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
33.3%
2/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.9%
2/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
8.1%
3/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Stricture, Gi - Stomach
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Nausea
|
57.6%
182/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
48.9%
223/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
57.6%
19/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
25.5%
42/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
16.7%
1/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
8.8%
3/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
16.2%
6/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
0.95%
3/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.2%
10/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Diarrhea
|
31.0%
98/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
32.5%
148/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
33.3%
11/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
18.2%
30/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
8.8%
3/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
10.8%
4/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Ulcer,gi - Small Bowel Nos
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Pharynx
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Hemorrhage, Gu - Urinary Nos
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.1%
5/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
2.5%
8/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.0%
9/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Hemorrhage, Gu - Urethra
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Hemorrhage/Pulmonary - Lung
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Hemorrhage, Gi - Rectum
|
1.9%
6/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.2%
19/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Hemorrhage/Pulmonary - Respiratory Tract Nos
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Hemorrhage, Gi - Stoma
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Hemorrhage, Gi - Varices (Rectal)
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Hemorrhage/Pulmonary - Nose
|
2.5%
8/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
25.4%
116/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
7.9%
13/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
8.8%
3/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Hematoma
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Hemorrhage, Gi - Anus
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.3%
6/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Hemorrhage, Gu - Ureter
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Hemorrhage, Gi - Lower Gi Nos
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Hemorrhage, Gi - Oral Cavity
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.7%
17/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
3/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Hemorrhage, Gu - Bladder
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Hemorrhage, Gi - Stomach
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Hemorrhage, Gi - Colon
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Petechiae
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.88%
4/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Hemorrhage/Bleeding - Other
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
3/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas - Other
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Hepatobiliary disorders
Liver Dysfunction
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Blood
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Febrile Neutropenia
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.0%
9/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Skin (Cellulitis)
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Middle Ear
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Vulva
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.88%
4/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos
|
3.2%
10/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.4%
20/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Nose
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)
|
1.3%
4/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.3%
6/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Larynx
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Eye Nos
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Meninges
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Brain
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Soft Tissue Nos
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Joint
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Blood
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Wound
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Oral Cavity-Gums
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.88%
4/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Otitis Media Nos
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)
|
1.9%
6/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.5%
7/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
16.7%
1/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.88%
4/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Lip/Perioral
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.88%
4/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf Unknown Anc: Lung (Pneumonia)
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf Unknown Anc: Nose
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf Unknown Anc: Sinus
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.88%
4/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.5%
7/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Colon
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
6.0%
19/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.5%
25/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
9.1%
3/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Ungual (Nails)
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Stomach
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Infection - Other
|
2.2%
7/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.1%
14/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Bladder (Urinary)
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Opportunisitic Inf Assoc. W/Gr 2 Lymphopenia
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Colitis, Infectious (Eg.C. Difficile)
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.88%
4/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Oral Cavity-Gums
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Conjunctiva
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus
|
1.6%
5/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Appendix
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf Unknown Anc: Upper Airway Nos
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.5%
7/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Pharynx
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Vagina
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.2%
10/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus
|
1.6%
5/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.4%
20/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf Unknown Anc: Pharynx
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf Unknown Anc: Bronchus
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf Unknown Anc: Eye Nos
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf Unknown Anc: Soft Tissue Nos
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf Unknown Anc: Urinary Tract Nos
|
1.9%
6/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.2%
10/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf Unknown Anc: Bladder (Urinary)
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf Unknown Anc: Catheter-Related
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf Unknown Anc: Oral Cavity-Gums
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Foreign Body
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf Unknown Anc: Dental-Tooth
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf Unknown Anc: Abdomen Nos
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf Unknown Anc: Skin (Cellulitis)
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf Unknown Anc: Middle Ear
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Vulva
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Vagina
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Upper Airway Nos
|
1.3%
4/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.3%
6/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.4%
4/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Anal/Perianal
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Sinus
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.88%
4/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Pharynx
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Nose
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Lung (Pneumonia)
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Bronchus
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Joint
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder
|
0.95%
3/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
8/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos
|
1.9%
6/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: External Ear
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Blood and lymphatic system disorders
Lymphedema-Related Fibrosis
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Blood and lymphatic system disorders
Lymphatics - Other
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Blood and lymphatic system disorders
Edema: Trunk/Genital
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Blood and lymphatic system disorders
Edema: Limb
|
12.7%
40/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
9.6%
44/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
9.1%
3/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.8%
8/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
16.7%
1/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
8.1%
3/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Blood and lymphatic system disorders
Edema: Head And Neck
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
8/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Ast
|
9.5%
30/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
13.6%
62/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
6.1%
2/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.6%
6/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.9%
2/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
8.1%
3/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Gfr
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.5%
7/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
3.2%
10/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.1%
14/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Cholesterol,serum High
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.7%
17/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Proteinuria
|
0.95%
3/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
15.4%
70/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
10.3%
17/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Creatinine
|
5.4%
17/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
11.4%
52/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
5/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.9%
2/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
40.0%
2/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.3%
20/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
9.4%
43/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.4%
4/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
8.8%
3/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Ggt
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.88%
4/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Alt
|
8.5%
27/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
9.0%
41/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
5/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
40.0%
2/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
8.1%
3/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
7.0%
22/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
7.7%
35/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
6.1%
2/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
8.1%
3/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Bilirubin
|
0.95%
3/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.6%
12/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Lipase
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
13/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.1%
13/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.8%
22/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
9.1%
3/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
3/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.0%
19/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
13.2%
60/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.4%
2/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.1%
5/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.95%
3/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.4%
11/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Cpk
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Bicarbonate, Serum-Low
|
0.95%
3/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.5%
7/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Amylase
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.6%
5/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.1%
5/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.1%
16/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
10.5%
48/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.6%
6/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.9%
2/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.2%
10/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.7%
26/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.8%
8/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
23.4%
74/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
24.3%
111/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
15.2%
5/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
6.1%
10/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
16.7%
1/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
8.8%
3/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
40.0%
2/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.4%
2/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.4%
33/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
10.5%
48/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
9.1%
3/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.2%
7/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.9%
2/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.2%
7/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.6%
21/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
3/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.9%
2/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.9%
6/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.4%
20/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
5/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.1%
51/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
22.8%
104/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
24.2%
8/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
7.9%
13/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/St: Other
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.4%
11/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.9%
2/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
Soft Tissue Necrosis - Abdomen
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
Joint-Function
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.88%
4/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
3/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
Extremity-Upper (Function)
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
Gait/Walking
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
Cervical Spine Rom
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.95%
3/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.4%
20/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
3/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Whole Body/Generalized
|
4.7%
15/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
7.0%
32/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
12.1%
4/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.6%
6/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.9%
2/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Right-Sided
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Left-Sided
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Upper
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Lower
|
2.5%
8/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.3%
15/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
12.1%
4/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.9%
2/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Syncope
|
0.95%
3/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
8/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Involuntary Movement
|
1.6%
5/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Neurology - Other
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.1%
5/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
16.7%
1/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Mental Status
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Mood Alteration - Depression
|
13.3%
42/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
11.2%
51/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
15.2%
5/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
7.3%
12/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
16.7%
1/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Mood Alteration - Anxiety
|
12.3%
39/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
12.5%
57/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
9.1%
3/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
7.9%
13/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Mood Alteration - Agitation
|
1.3%
4/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Tremor
|
1.3%
4/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.88%
4/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Speech Impairment
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.1%
5/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Seizure
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Irritability
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Cognitive Disturbance
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Cns Ischemia
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Ataxia
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
16.7%
1/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Confusion
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.3%
6/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Memory Impairment
|
2.2%
7/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.5%
16/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
3/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Dizziness
|
7.6%
24/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
11.2%
51/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
12.1%
4/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.8%
8/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
16.7%
1/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.9%
2/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Neuropathy,cranial - Cn Xii Motor-Tongue
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Neuropathy,cranial - Cn Viii Hearing/Balance
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Neuropathy,cranial - Cn Vii Motor-Face
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Neuropathy,cranial - Cn Iii Pupil
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Neuropathy,cranial - Cn I Smell
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Neuropathy-Sensory
|
75.0%
237/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
59.6%
272/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
54.5%
18/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
33.3%
55/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
50.0%
3/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
11.8%
4/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
13.5%
5/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Nervous system disorders
Neuropathy-Motor
|
4.7%
15/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.1%
14/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
6.1%
2/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
5/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
16.7%
1/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Eye disorders
Ocular/Visual - Other
|
1.9%
6/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.4%
11/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
16.7%
1/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Eye disorders
Scleral Necrosis
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Eye disorders
Watery Eye
|
2.2%
7/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.5%
7/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Eye disorders
Dry Eye
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.1%
5/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Eye disorders
Ocular Surface Disease
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Eye disorders
Cataract
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.88%
4/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Eye disorders
Photophobia
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Eye disorders
Flashing Lights/Floaters
|
1.9%
6/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.2%
19/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
3/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Eye disorders
Diplopia
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Eye disorders
Blurred Vision
|
11.4%
36/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
12.1%
55/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
6.1%
2/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.4%
4/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Eye disorders
Eyelid Dysfunction
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
16.7%
1/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain - Other
|
1.9%
6/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.8%
22/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
6.1%
2/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
3/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
16.7%
1/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Urethra
|
0.95%
3/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Perineum
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Pelvis
|
3.2%
10/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.4%
11/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
6.1%
2/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.4%
4/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Breast
|
1.3%
4/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Vagina
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Chest /Thorax Nos
|
1.9%
6/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.0%
23/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
5/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Chest Wall
|
3.2%
10/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.7%
17/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Throat/Pharynx/Larynx
|
2.8%
9/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
6.8%
31/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.4%
4/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Pleura
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Larynx
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Eye
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.3%
6/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Head/Headache
|
18.7%
59/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
31.1%
142/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
21.2%
7/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
11.5%
19/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
33.3%
2/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
11.8%
4/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.4%
2/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Neck
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
7.2%
33/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Extremity-Limb
|
13.0%
41/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
21.3%
97/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
21.2%
7/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
7.9%
13/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Buttock
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.1%
5/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Back
|
11.1%
35/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
14.3%
65/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
9.1%
3/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
7.9%
13/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.4%
2/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Joint
|
31.3%
99/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
36.4%
166/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
12.1%
4/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
17.0%
28/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
16.7%
1/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.9%
2/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
8.1%
3/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Bone
|
6.0%
19/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
7.2%
33/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
9.1%
3/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.8%
8/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Kidney
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Bladder
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.88%
4/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
6.1%
2/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Pain Nos
|
1.3%
4/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
8/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.2%
7/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Stomach
|
0.95%
3/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.0%
9/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Rectum
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.3%
6/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Oral Cavity
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
13/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.4%
4/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Esophagus
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Dental/Teeth/Peridontal
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.0%
9/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.4%
2/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Abdominal Pain Nos
|
26.6%
84/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
27.9%
127/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
48.5%
16/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
21.8%
36/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
33.3%
2/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.9%
2/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
10.8%
4/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Scalp
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Oral - Gums
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.88%
4/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Skin
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Lip
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Middle Ear
|
1.6%
5/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
8/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: External Ear
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.88%
4/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Cardiac/ Heart
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Face
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.3%
6/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Tumor
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Muscle
|
17.4%
55/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
23.5%
107/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
12.1%
4/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
13.9%
23/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Anus
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Neuralgia
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.88%
4/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
16.7%
1/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Pain: Sinus
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.3%
6/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary: Other
|
0.95%
3/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.2%
10/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
Airway Obstruction - Larynx
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
Airway Obstruction - Bronchus
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/Paranasal Reactions
|
2.5%
8/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
11.0%
50/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.2%
7/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
16.7%
1/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.4%
2/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
Edema, Larynx
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.95%
3/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
1.9%
6/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
12.1%
55/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.8%
8/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.8%
53/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
24.1%
110/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
15.2%
5/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
8.5%
14/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
16.7%
1/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.9%
2/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.7%
1/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.3%
80/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
24.1%
110/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
12.1%
4/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
9.1%
15/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
33.3%
2/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
5.4%
2/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.2%
10/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
16.7%
1/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.2%
10/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
3/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Renal and urinary disorders
Urinary Color Change
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Renal and urinary disorders
Urinary Retention
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.3%
6/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Renal and urinary disorders
Obstruction, Gu - Urethra
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Renal and urinary disorders
Obstruction, Gu - Ureter
|
0.95%
3/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Renal and urinary disorders
Incontinence, Urinary
|
5.1%
16/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
4.4%
20/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.0%
1/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
3/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Renal and urinary disorders
Bladder Spasm
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Renal and urinary disorders
Urinary Frequency
|
7.9%
25/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
7.7%
35/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
9.1%
3/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.4%
4/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
16.7%
1/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
20.0%
1/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
2nd Mal: Poss. Related To Cancer Rx
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Reproductive system and breast disorders
Libido
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
1.3%
4/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.5%
7/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.8%
3/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Reproductive system and breast disorders
Sexual/Reproductive Function: Other
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Reproductive system and breast disorders
Vaginitis
|
0.63%
2/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
1.3%
4/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.2%
10/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Cytokine Release Syndrome
|
1.3%
4/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
General disorders
Flu-Like Syndrome
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
3.7%
17/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.4%
4/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Vascular - Other
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.44%
2/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Visceral Arterial Ischemia
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Vein Injury - Extremity-Lower
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Artery Injury - Other Nos
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.22%
1/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Thrombosis/Embolism (Vascular Access-Related)
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.66%
3/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.9%
1/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
0.00%
0/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
2.4%
11/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.2%
2/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
|
Vascular disorders
Phlebitis
|
0.32%
1/316 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
1.1%
5/456 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/33 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.61%
1/165 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
16.7%
1/6 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/34 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/5 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
0.00%
0/37 • During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
|
Additional Information
Christopher Purdy on behalf of Austin Miller PhD
NRG Oncology
Phone: (716) 845-1300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60