Trial Outcomes & Findings for Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer (NCT NCT00079274)
NCT ID: NCT00079274
Last Updated: 2020-05-13
Results Overview
The primary endpoint for this study was to compare the disease-free survival (DFS) in patients with stage III colon cancer who are KRAS wild-type randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint. Disease-free survival is defined as the time from randomization until tumor recurrence or death, whichever is first. Estimated by the method of Kaplan and Meier.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3397 participants
Primary outcome timeframe
At 3 years
Results posted on
2020-05-13
Participant Flow
Participant milestones
| Measure |
Arm A (Combination Chemotherapy)
Patients received oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
|
Arm B (Combination Chemotherapy)
Patients received irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
irinotecan hydrochloride: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
|
Arm C (Combination Chemotherapy)
Patients received the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.
irinotecan hydrochloride: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
|
Arm D (Combination Chemotherapy, Monoclonal Antibody)
Patients received cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
cetuximab: Given IV
|
Arm E (Combination Chemotherapy, Monoclonal Antibody)
Patients received cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
irinotecan hydrochloride: Given IV
leucovorin calcium: Given IV
fluorouracil: Given I
cetuximab: Given IV
|
Arm F (Combination Chemotherapy, Monoclonal Antibody)
Patients received cetuximab as in arm D and chemotherapy as in arm C.
irinotecan hydrochloride: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
cetuximab: Given IV
|
Arm G (Locally Directed Therapy)
Patients determined to have mutated Kirsten rat sarcoma (KRAS) (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists.
Locally Directed Therapy: Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1402
|
111
|
111
|
1350
|
45
|
46
|
332
|
|
Overall Study
COMPLETED
|
1081
|
84
|
84
|
906
|
30
|
26
|
332
|
|
Overall Study
NOT COMPLETED
|
321
|
27
|
27
|
444
|
15
|
20
|
0
|
Reasons for withdrawal
| Measure |
Arm A (Combination Chemotherapy)
Patients received oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
|
Arm B (Combination Chemotherapy)
Patients received irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
irinotecan hydrochloride: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
|
Arm C (Combination Chemotherapy)
Patients received the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.
irinotecan hydrochloride: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
|
Arm D (Combination Chemotherapy, Monoclonal Antibody)
Patients received cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
cetuximab: Given IV
|
Arm E (Combination Chemotherapy, Monoclonal Antibody)
Patients received cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
irinotecan hydrochloride: Given IV
leucovorin calcium: Given IV
fluorouracil: Given I
cetuximab: Given IV
|
Arm F (Combination Chemotherapy, Monoclonal Antibody)
Patients received cetuximab as in arm D and chemotherapy as in arm C.
irinotecan hydrochloride: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
cetuximab: Given IV
|
Arm G (Locally Directed Therapy)
Patients determined to have mutated Kirsten rat sarcoma (KRAS) (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists.
Locally Directed Therapy: Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
111
|
10
|
12
|
163
|
7
|
8
|
0
|
|
Overall Study
Adverse Event
|
130
|
8
|
8
|
184
|
7
|
8
|
0
|
|
Overall Study
Recurrence
|
21
|
0
|
1
|
15
|
0
|
2
|
0
|
|
Overall Study
Alternate Treatment
|
6
|
1
|
0
|
3
|
0
|
0
|
0
|
|
Overall Study
Other Medical Problems
|
6
|
1
|
0
|
7
|
0
|
0
|
0
|
|
Overall Study
Death
|
4
|
0
|
1
|
15
|
0
|
0
|
0
|
|
Overall Study
Cytogenetic resistance
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Other
|
43
|
7
|
5
|
55
|
1
|
2
|
0
|
Baseline Characteristics
Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer
Baseline characteristics by cohort
| Measure |
Arm A (Combination Chemotherapy)
n=1402 Participants
Patients received oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
|
Arm B (Combination Chemotherapy)
n=111 Participants
Patients received irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
irinotecan hydrochloride: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
|
Arm C (Combination Chemotherapy)
n=111 Participants
Patients received the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.
irinotecan hydrochloride: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
|
Arm D (Combination Chemotherapy, Monoclonal Antibody)
n=1350 Participants
Patients received cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
cetuximab: Given IV
|
Arm E (Combination Chemotherapy, Monoclonal Antibody)
n=45 Participants
Patients received cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
irinotecan hydrochloride: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
cetuximab: Given IV
|
Arm F (Combination Chemotherapy, Monoclonal Antibody)
n=46 Participants
Patients received cetuximab as in arm D and chemotherapy as in arm C.
irinotecan hydrochloride: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
cetuximab: Given IV
|
Arm G (Locally Directed Therapy)
n=332 Participants
Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists.
Locally Directed Therapy: Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists.
|
Total
n=3397 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Histologic Grade
High
|
357 participants
n=5 Participants
|
25 participants
n=7 Participants
|
28 participants
n=5 Participants
|
345 participants
n=4 Participants
|
10 participants
n=21 Participants
|
12 participants
n=8 Participants
|
60 participants
n=8 Participants
|
837 participants
n=24 Participants
|
|
Tumor Stage
Not Availabe
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
2 participants
n=24 Participants
|
|
Histologic Grade
Low
|
1045 participants
n=5 Participants
|
86 participants
n=7 Participants
|
83 participants
n=5 Participants
|
1005 participants
n=4 Participants
|
35 participants
n=21 Participants
|
34 participants
n=8 Participants
|
272 participants
n=8 Participants
|
2560 participants
n=24 Participants
|
|
Age, Continuous
|
58 years
n=5 Participants
|
57 years
n=7 Participants
|
60 years
n=5 Participants
|
58 years
n=4 Participants
|
59 years
n=21 Participants
|
60.5 years
n=8 Participants
|
56 years
n=8 Participants
|
58 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
662 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
647 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
160 Participants
n=8 Participants
|
1613 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
740 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
703 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
172 Participants
n=8 Participants
|
1784 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
64 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
158 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1107 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
1060 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
41 Participants
n=8 Participants
|
225 Participants
n=8 Participants
|
2677 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
231 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
228 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
89 Participants
n=8 Participants
|
562 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
66 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
149 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
94 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
239 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
1202 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
1154 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
43 Participants
n=8 Participants
|
275 Participants
n=8 Participants
|
2909 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
59 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
1258 participants
n=5 Participants
|
109 participants
n=7 Participants
|
109 participants
n=5 Participants
|
1224 participants
n=4 Participants
|
44 participants
n=21 Participants
|
46 participants
n=8 Participants
|
303 participants
n=8 Participants
|
3093 participants
n=24 Participants
|
|
Region of Enrollment
Canada
|
138 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
124 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
28 participants
n=8 Participants
|
295 participants
n=24 Participants
|
|
Region of Enrollment
Jamaica
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
1 participants
n=24 Participants
|
|
Region of Enrollment
Puerto Rico
|
5 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
8 participants
n=24 Participants
|
|
Positive Nodes
1-3
|
816 participants
n=5 Participants
|
71 participants
n=7 Participants
|
70 participants
n=5 Participants
|
790 participants
n=4 Participants
|
29 participants
n=21 Participants
|
28 participants
n=8 Participants
|
203 participants
n=8 Participants
|
2007 participants
n=24 Participants
|
|
Positive Nodes
4+
|
586 participants
n=5 Participants
|
40 participants
n=7 Participants
|
41 participants
n=5 Participants
|
560 participants
n=4 Participants
|
16 participants
n=21 Participants
|
18 participants
n=8 Participants
|
129 participants
n=8 Participants
|
1390 participants
n=24 Participants
|
|
Tumor Stage
T1 or T2
|
198 participants
n=5 Participants
|
18 participants
n=7 Participants
|
14 participants
n=5 Participants
|
213 participants
n=4 Participants
|
5 participants
n=21 Participants
|
5 participants
n=8 Participants
|
56 participants
n=8 Participants
|
509 participants
n=24 Participants
|
|
Tumor Stage
T3
|
1046 participants
n=5 Participants
|
78 participants
n=7 Participants
|
93 participants
n=5 Participants
|
983 participants
n=4 Participants
|
35 participants
n=21 Participants
|
39 participants
n=8 Participants
|
214 participants
n=8 Participants
|
2488 participants
n=24 Participants
|
|
Tumor Stage
T4
|
158 participants
n=5 Participants
|
15 participants
n=7 Participants
|
4 participants
n=5 Participants
|
153 participants
n=4 Participants
|
4 participants
n=21 Participants
|
2 participants
n=8 Participants
|
62 participants
n=8 Participants
|
398 participants
n=24 Participants
|
|
KRAS Status
Unknown
|
56 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
51 participants
n=4 Participants
|
3 participants
n=21 Participants
|
4 participants
n=8 Participants
|
6 participants
n=8 Participants
|
132 participants
n=24 Participants
|
|
KRAS Status
Mutant
|
391 participants
n=5 Participants
|
33 participants
n=7 Participants
|
43 participants
n=5 Participants
|
345 participants
n=4 Participants
|
15 participants
n=21 Participants
|
13 participants
n=8 Participants
|
326 participants
n=8 Participants
|
1166 participants
n=24 Participants
|
|
KRAS Status
Wildtype
|
955 participants
n=5 Participants
|
72 participants
n=7 Participants
|
62 participants
n=5 Participants
|
954 participants
n=4 Participants
|
27 participants
n=21 Participants
|
29 participants
n=8 Participants
|
0 participants
n=8 Participants
|
2099 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: At 3 yearsPopulation: The analysis was performed using intention to treat principles. All patients that were wild-type KRAS and received randomized treatment according to the Arm A or Arm D intervention schedule were evaluated for this endpoint. Any patient receiving irinotecan was not included in the evaluation of this endpoint.
The primary endpoint for this study was to compare the disease-free survival (DFS) in patients with stage III colon cancer who are KRAS wild-type randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint. Disease-free survival is defined as the time from randomization until tumor recurrence or death, whichever is first. Estimated by the method of Kaplan and Meier.
Outcome measures
| Measure |
Wild-type KRAS Arm A
n=909 Participants
Patients from Arm A (and a few patients from Arm C that did not receive irinotecan) that are wild-type KRAS and concurrently randomized with Arm D patients.
|
Wild-type KRAS Arm D
n=954 Participants
Patients from Arm D (and a few patients from Arm F that did not receive irinotecan) that are wild-type KRAS and concurrently randomized with Arm A patients.
|
|---|---|---|
|
Disease-free Survival (Arms A and D: Wild-type KRAS Patients)
|
74.6 percentage of participants
Interval 71.1 to 78.3
|
71.5 percentage of participants
Interval 67.8 to 75.4
|
SECONDARY outcome
Timeframe: At 3 yearsPopulation: The analysis was performed using intention to treat principles. All patients that were KRAS mutant (or not evaluable for KRAS) and received randomized treatment according to the Arm A or Arm D intervention schedule were evaluated for this endpoint. Any patient receiving irinotecan was not included in the evaluation of this endpoint.
A secondary endpoint for this study was to investigate the disease-free survival (DFS) in patients with stage III colon cancer who are KRAS mutant (or KRAS-nonevaluable) and randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint. Disease-free survival is defined as the time from randomization until tumor recurrence or death, whichever is first. Estimated by the method of Kaplan and Meier.
Outcome measures
| Measure |
Wild-type KRAS Arm A
n=374 Participants
Patients from Arm A (and a few patients from Arm C that did not receive irinotecan) that are wild-type KRAS and concurrently randomized with Arm D patients.
|
Wild-type KRAS Arm D
n=343 Participants
Patients from Arm D (and a few patients from Arm F that did not receive irinotecan) that are wild-type KRAS and concurrently randomized with Arm A patients.
|
|---|---|---|
|
Disease-free Survival (Arms A and D: Mutant KRAS Patients)
|
67.1 percentage of participants
Interval 61.8 to 72.8
|
65.0 percentage of participants
Interval 59.8 to 70.7
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: The analysis was performed using intention to treat principles. All patients that were wild-type KRAS and received randomized treatment according to the Arm A or Arm D intervention schedule were evaluated for this endpoint. Any patient receiving irinotecan was not included in the evaluation of this endpoint.
Evidence of death from any cause within 3 years counted as events in the time to event- Kaplan Meier analysis of overall survival for patients with stage III colon cancer who are KRAS wild-type randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint. The 3-year event free rates (percentage) are reported below for Wild-type KRAS Patients.
Outcome measures
| Measure |
Wild-type KRAS Arm A
n=909 Participants
Patients from Arm A (and a few patients from Arm C that did not receive irinotecan) that are wild-type KRAS and concurrently randomized with Arm D patients.
|
Wild-type KRAS Arm D
n=954 Participants
Patients from Arm D (and a few patients from Arm F that did not receive irinotecan) that are wild-type KRAS and concurrently randomized with Arm A patients.
|
|---|---|---|
|
Overall Survival as Measured by the 3-year Event-free Rate (Arms A and D: Wild-type KRAS Patients)
|
87.3 percentage of participants
Interval 84.3 to 90.3
|
85.6 percentage of participants
Interval 82.7 to 88.7
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: The analysis was performed using intention to treat principles. All patients that were KRAS mutant (or not evaluable for KRAS) and received randomized treatment according to the Arm A or Arm D intervention schedule were evaluated for this endpoint. Any patient receiving irinotecan was not included in the evaluation of this endpoint.
Evidence of death from any cause within 3 years counted as events in the time to event- Kaplan Meier analysis of overall survival for patients with stage III colon cancer who are KRAS mutant (or KRAS-nonevaluable) and randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint. The 3-year event-free rates (percentage) are report below for mutant KRAS patients.
Outcome measures
| Measure |
Wild-type KRAS Arm A
n=374 Participants
Patients from Arm A (and a few patients from Arm C that did not receive irinotecan) that are wild-type KRAS and concurrently randomized with Arm D patients.
|
Wild-type KRAS Arm D
n=343 Participants
Patients from Arm D (and a few patients from Arm F that did not receive irinotecan) that are wild-type KRAS and concurrently randomized with Arm A patients.
|
|---|---|---|
|
Overall Survival as Measured by the 3-year Event-free Rate (Arms A and D: Mutant KRAS Patients)
|
87.9 percentage of participants
Interval 84.0 to 91.9
|
82.7 percentage of participants
Interval 78.0 to 87.6
|
SECONDARY outcome
Timeframe: Assessed up to 8 yearsPopulation: All patients that were wild-type KRAS and received randomized treatment according to the Arm A or Arm D intervention schedule and completed the adverse event form at least once were evaluated for this endpoint.
The maximum grade for each type of toxicity will be recorded for each patient with stage III colon cancer who are KRAS wild-type randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below.
Outcome measures
| Measure |
Wild-type KRAS Arm A
n=894 Participants
Patients from Arm A (and a few patients from Arm C that did not receive irinotecan) that are wild-type KRAS and concurrently randomized with Arm D patients.
|
Wild-type KRAS Arm D
n=931 Participants
Patients from Arm D (and a few patients from Arm F that did not receive irinotecan) that are wild-type KRAS and concurrently randomized with Arm A patients.
|
|---|---|---|
|
Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (v3) (Arms A and D: Wild-type KRAS Patients)
|
51.1 percentage of patients
|
73.3 percentage of patients
|
SECONDARY outcome
Timeframe: Assessed up to 8 yearsPopulation: All patients that were mutant KRAS and received randomized treatment according to the Arm A or Arm D intervention schedule and completed the adverse event form at least once were evaluated for this endpoint.
The maximum grade for each type of toxicity will be recorded for each patient with stage III colon cancer who are KRAS mutant (or KRAS-nonevaluable) and randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below.
Outcome measures
| Measure |
Wild-type KRAS Arm A
n=367 Participants
Patients from Arm A (and a few patients from Arm C that did not receive irinotecan) that are wild-type KRAS and concurrently randomized with Arm D patients.
|
Wild-type KRAS Arm D
n=342 Participants
Patients from Arm D (and a few patients from Arm F that did not receive irinotecan) that are wild-type KRAS and concurrently randomized with Arm A patients.
|
|---|---|---|
|
Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (v3) (Arms A and D: Mutant KRAS Patients)
|
55.6 percentage of patients
|
72.3 percentage of patients
|
Adverse Events
Arm A (Combination Chemotherapy)
Serious events: 93 serious events
Other events: 688 other events
Deaths: 0 deaths
Arm B (Combination Chemotherapy)
Serious events: 9 serious events
Other events: 53 other events
Deaths: 0 deaths
Arm C (Combination Chemotherapy)
Serious events: 11 serious events
Other events: 60 other events
Deaths: 0 deaths
Arm D (Combination Chemotherapy, Monoclonal Antibody)
Serious events: 150 serious events
Other events: 928 other events
Deaths: 0 deaths
Arm E (Combination Chemotherapy, Monoclonal Antibody)
Serious events: 4 serious events
Other events: 26 other events
Deaths: 0 deaths
Arm F (Combination Chemotherapy, Monoclonal Antibody)
Serious events: 5 serious events
Other events: 33 other events
Deaths: 0 deaths
Arm G (Locally Directed Therapy)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Combination Chemotherapy)
n=1378 participants at risk
Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
|
Arm B (Combination Chemotherapy)
n=108 participants at risk
Patients receive irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
irinotecan hydrochloride: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
|
Arm C (Combination Chemotherapy)
n=108 participants at risk
Patients receive the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.
irinotecan hydrochloride: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
|
Arm D (Combination Chemotherapy, Monoclonal Antibody)
n=1326 participants at risk
Patients receive cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
cetuximab: Given IV
|
Arm E (Combination Chemotherapy, Monoclonal Antibody)
n=42 participants at risk
Patients receive cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
irinotecan hydrochloride: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
cetuximab: Given IV
|
Arm F (Combination Chemotherapy, Monoclonal Antibody)
n=44 participants at risk
Patients receive cetuximab as in arm D and chemotherapy as in arm C.
irinotecan hydrochloride: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
cetuximab: Given IV
|
Arm G (Locally Directed Therapy)
Patients determined to have mutated KRAS (or KRAS not evaluable) will be assigned to an event monitoring arm in which adjuvant therapy will be determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification will be the responsibility of the treating oncologists.
Locally Directed Therapy: Patients determined to have mutated KRAS (or KRAS not evaluable) will be assigned to an event monitoring arm in which adjuvant therapy will be determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification will be the responsibility of the treating oncologists.
|
|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Asystole
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.30%
4/1326 • Number of events 4 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Cardiac disorder
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Cardiac pain
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
1/42 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Cardiopulmonary arrest
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Left ventricular failure
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
1/42 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Myocardial ischemia
|
0.44%
6/1378 • Number of events 7 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.68%
9/1326 • Number of events 9 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
1/42 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Premature ventricular contractions
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Colitis
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Colonic perforation
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Colonic stenosis
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Diarrhea
|
1.1%
15/1378 • Number of events 15 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.5%
20/1326 • Number of events 20 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Endoscopy small intestine abnormal
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Esophageal ulcer
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Ileus
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.23%
3/1326 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Nausea
|
0.36%
5/1378 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.38%
5/1326 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Vomiting
|
0.22%
3/1378 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.38%
5/1326 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
General disorders
Chest pain
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
General disorders
Death NOS
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
General disorders
Fatigue
|
0.22%
3/1378 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.30%
4/1326 • Number of events 4 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
General disorders
Sudden death
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Immune system disorders
Hypersensitivity
|
0.44%
6/1378 • Number of events 6 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.3%
17/1326 • Number of events 17 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Bladder infection
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Catheter related infection
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Infectious meningitis
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Pneumonia
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Sepsis
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.53%
7/1326 • Number of events 7 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Skin infection
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Urinary tract infection
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Wound infection
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Alanine aminotransferase increased
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Amylase increased
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Aspartate aminotransferase increased
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Blood bilirubin increased
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
4.8%
2/42 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Cardiac troponin T increased
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Creatine phosphokinase increased
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Creatinine increased
|
0.22%
3/1378 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
INR increased
|
0.29%
4/1378 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Lipase increased
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Neutrophil count decreased
|
0.94%
13/1378 • Number of events 15 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.60%
8/1326 • Number of events 8 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Weight loss
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.22%
3/1378 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.30%
4/1326 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
0.22%
3/1378 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.38%
5/1326 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.51%
7/1378 • Number of events 7 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.9%
2/108 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.75%
10/1326 • Number of events 10 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.45%
6/1326 • Number of events 6 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.73%
10/1378 • Number of events 10 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.5%
20/1326 • Number of events 20 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Ataxia
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.23%
3/1326 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Headache
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.30%
4/1326 • Number of events 4 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.22%
3/1378 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.23%
3/1326 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.07%
1/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.07%
1/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Seizure
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Syncope
|
0.44%
6/1378 • Number of events 6 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.9%
2/108 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.38%
5/1326 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
1/42 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Psychiatric disorders
Depression
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Renal and urinary disorders
Bladder hemorrhage
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.9%
2/108 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.45%
6/1326 • Number of events 6 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
4.8%
2/42 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
4.5%
2/44 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.23%
3/1326 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.38%
5/1326 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
1/42 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Skin and subcutaneous tissue disorders
Masculinization
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.23%
3/1326 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Vascular disorders
Hypotension
|
0.22%
3/1378 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.38%
5/1326 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Vascular disorders
Thrombosis
|
0.36%
5/1378 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.9%
2/108 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.68%
9/1326 • Number of events 9 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
Other adverse events
| Measure |
Arm A (Combination Chemotherapy)
n=1378 participants at risk
Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
|
Arm B (Combination Chemotherapy)
n=108 participants at risk
Patients receive irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
irinotecan hydrochloride: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
|
Arm C (Combination Chemotherapy)
n=108 participants at risk
Patients receive the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.
irinotecan hydrochloride: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
|
Arm D (Combination Chemotherapy, Monoclonal Antibody)
n=1326 participants at risk
Patients receive cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
cetuximab: Given IV
|
Arm E (Combination Chemotherapy, Monoclonal Antibody)
n=42 participants at risk
Patients receive cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.
irinotecan hydrochloride: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
cetuximab: Given IV
|
Arm F (Combination Chemotherapy, Monoclonal Antibody)
n=44 participants at risk
Patients receive cetuximab as in arm D and chemotherapy as in arm C.
irinotecan hydrochloride: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
cetuximab: Given IV
|
Arm G (Locally Directed Therapy)
Patients determined to have mutated KRAS (or KRAS not evaluable) will be assigned to an event monitoring arm in which adjuvant therapy will be determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification will be the responsibility of the treating oncologists.
Locally Directed Therapy: Patients determined to have mutated KRAS (or KRAS not evaluable) will be assigned to an event monitoring arm in which adjuvant therapy will be determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification will be the responsibility of the treating oncologists.
|
|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Injury, poisoning and procedural complications
Injury to superior vena cava
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Injury, poisoning and procedural complications
Intestinal stoma site bleeding
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.6%
22/1378 • Number of events 33 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.8%
3/108 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
4.6%
5/108 • Number of events 8 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.4%
18/1326 • Number of events 34 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
1/42 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
4.5%
2/44 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.07%
1/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.30%
4/1326 • Number of events 4 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Alanine aminotransferase increased
|
1.2%
16/1378 • Number of events 21 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.1%
14/1326 • Number of events 18 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
1/42 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Alkaline phosphatase increased
|
0.15%
2/1378 • Number of events 4 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Aspartate aminotransferase increased
|
0.73%
10/1378 • Number of events 10 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.83%
11/1326 • Number of events 12 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
1/42 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Blood bilirubin increased
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Coagulopathy
|
0.22%
3/1378 • Number of events 7 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.23%
3/1326 • Number of events 10 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Creatinine increased
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.15%
2/1378 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 4 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
INR increased
|
1.2%
16/1378 • Number of events 39 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.1%
15/1326 • Number of events 30 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Leukocyte count decreased
|
1.8%
25/1378 • Number of events 32 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
31/1326 • Number of events 36 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Lipase increased
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Lymphocyte count decreased
|
0.36%
5/1378 • Number of events 6 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.60%
8/1326 • Number of events 14 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.29%
4/1378 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.68%
9/1326 • Number of events 12 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Neutrophil count decreased
|
9.5%
131/1378 • Number of events 148 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
13.0%
14/108 • Number of events 18 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
16.7%
18/108 • Number of events 20 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
11.6%
154/1326 • Number of events 175 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
7.1%
3/42 • Number of events 4 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
9.1%
4/44 • Number of events 4 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Platelet count decreased
|
0.44%
6/1378 • Number of events 6 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.30%
4/1326 • Number of events 4 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Serum cholesterol increased
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Weight gain
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 4 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Investigations
Weight loss
|
0.15%
2/1378 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.68%
9/1326 • Number of events 18 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.65%
9/1378 • Number of events 9 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.1%
28/1326 • Number of events 35 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
1/42 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
4.5%
2/44 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
3.0%
42/1378 • Number of events 99 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
7.4%
8/108 • Number of events 37 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
5.6%
6/108 • Number of events 12 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
32/1326 • Number of events 69 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
1/42 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 6 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.73%
10/1378 • Number of events 10 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.8%
3/108 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.9%
39/1326 • Number of events 42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
0.15%
2/1378 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.60%
8/1326 • Number of events 11 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
0.44%
6/1378 • Number of events 6 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.68%
9/1326 • Number of events 9 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.0%
26/1326 • Number of events 43 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
4.5%
2/44 • Number of events 4 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.15%
2/1378 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.68%
9/1326 • Number of events 13 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
2.4%
33/1378 • Number of events 43 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.9%
2/108 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
6.3%
84/1326 • Number of events 120 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
4.5%
2/44 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.15%
2/1378 • Number of events 4 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.45%
6/1326 • Number of events 6 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.29%
4/1378 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.23%
3/1326 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.22%
3/1378 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
1/42 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.29%
4/1378 • Number of events 4 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.38%
5/1326 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.22%
3/1378 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.30%
4/1326 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.07%
1/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Acoustic nerve disorder NOS
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Ataxia
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.30%
4/1326 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Dizziness
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.90%
12/1326 • Number of events 14 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Encephalopathy
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Headache
|
0.29%
4/1378 • Number of events 8 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.9%
2/108 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.75%
10/1326 • Number of events 12 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Laryngeal
|
0.51%
7/1378 • Number of events 11 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.8%
3/108 • Number of events 7 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.23%
3/1326 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 4 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Neurological disorder NOS
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Paresthesias
|
12.3%
169/1378 • Number of events 295 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.8%
3/108 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
9.1%
121/1326 • Number of events 220 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
9.5%
4/42 • Number of events 7 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.44%
6/1378 • Number of events 10 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.75%
10/1326 • Number of events 14 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.9%
67/1378 • Number of events 116 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.9%
2/108 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
5.1%
67/1326 • Number of events 109 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
1/42 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
4.5%
2/44 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Seizure
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Syncope
|
0.36%
5/1378 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.60%
8/1326 • Number of events 10 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.23%
3/1326 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Trigeminal nerve disorder
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Nervous system disorders
Vagus nerve disorder
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Psychiatric disorders
Anxiety
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 6 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Psychiatric disorders
Confusion
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Psychiatric disorders
Depression
|
0.15%
2/1378 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.30%
4/1326 • Number of events 7 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Psychiatric disorders
Insomnia
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.45%
6/1326 • Number of events 6 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Renal and urinary disorders
Kidney pain
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.23%
3/1326 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Renal and urinary disorders
Renal failure
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Renal and urinary disorders
Urinary retention
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.23%
3/1326 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.58%
8/1378 • Number of events 9 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.90%
12/1326 • Number of events 18 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
4.5%
2/44 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.94%
13/1378 • Number of events 18 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.9%
2/108 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.1%
28/1326 • Number of events 32 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
1/42 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.36%
5/1378 • Number of events 6 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.38%
5/1326 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.60%
8/1326 • Number of events 9 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
4.5%
2/44 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.38%
5/1326 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
4.5%
2/44 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.58%
8/1378 • Number of events 9 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.23%
3/1326 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.83%
11/1326 • Number of events 15 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
1/42 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
1.2%
16/1378 • Number of events 19 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.9%
2/108 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
3.0%
40/1326 • Number of events 56 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
1/42 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
4.5%
2/44 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.07%
1/1378 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.8%
24/1326 • Number of events 38 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
4.8%
2/42 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 4 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.23%
3/1326 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
11.8%
156/1326 • Number of events 259 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
16.7%
7/42 • Number of events 11 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
15.9%
7/44 • Number of events 12 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
0.15%
2/1378 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
8.7%
116/1326 • Number of events 194 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
9.5%
4/42 • Number of events 8 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
18.2%
8/44 • Number of events 12 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.30%
4/1326 • Number of events 4 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
1/42 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Vascular disorders
Flushing
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Vascular disorders
Hematoma
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Vascular disorders
Hot flashes
|
0.07%
1/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 4 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Vascular disorders
Hypertension
|
0.51%
7/1378 • Number of events 9 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.30%
4/1326 • Number of events 7 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.53%
7/1326 • Number of events 7 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Vascular disorders
Thrombosis
|
3.1%
43/1378 • Number of events 74 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.8%
3/108 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
4.6%
5/108 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
3.7%
49/1326 • Number of events 69 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
4.8%
2/42 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Vascular disorders
Vascular disorder
|
0.07%
1/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Cecal obstruction
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Immune system disorders
Cytokine release syndrome
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Immune system disorders
Hypersensitivity
|
2.0%
28/1378 • Number of events 29 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.9%
2/108 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
4.7%
62/1326 • Number of events 65 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
1/42 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.87%
12/1378 • Number of events 12 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.9%
2/108 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.8%
3/108 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
30/1326 • Number of events 33 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
1/42 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
0.44%
6/1378 • Number of events 9 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.60%
8/1326 • Number of events 11 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.23%
3/1326 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Arrhythmia
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Asystole
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Atrial fibrillation
|
0.07%
1/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Cardiac disorder
|
0.15%
2/1378 • Number of events 4 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Cardiac pain
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Myocardial ischemia
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.30%
4/1326 • Number of events 4 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
4.8%
2/42 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Premature ventricular contractions
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Eye disorders
Cataract
|
0.07%
1/1378 • Number of events 8 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Eye disorders
Watering eyes
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
31/1378 • Number of events 32 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.9%
2/108 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.1%
28/1326 • Number of events 35 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
1/42 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
6.8%
3/44 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Anal pain
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Colitis
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Colonic stenosis
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Constipation
|
0.22%
3/1378 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.68%
9/1326 • Number of events 10 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Diarrhea
|
7.8%
107/1378 • Number of events 125 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
13.9%
15/108 • Number of events 28 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
12.0%
13/108 • Number of events 17 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
14.5%
192/1326 • Number of events 250 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
14.3%
6/42 • Number of events 7 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
15.9%
7/44 • Number of events 11 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.23%
3/1326 • Number of events 4 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
1.3%
18/1378 • Number of events 20 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.9%
2/108 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.9%
2/108 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
4.8%
63/1326 • Number of events 77 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
7.1%
3/42 • Number of events 4 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Enteritis
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Esophagitis
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.23%
3/1326 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Ileal obstruction
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Ileal perforation
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Ileus
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.30%
4/1326 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Intestinal necrosis
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Large intestinal mucositis
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Mucositis oral
|
1.3%
18/1378 • Number of events 19 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.9%
2/108 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.9%
2/108 • Number of events 6 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
3.3%
44/1326 • Number of events 51 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
7.1%
3/42 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
4.5%
2/44 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Nausea
|
2.5%
35/1378 • Number of events 41 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
8.3%
9/108 • Number of events 10 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
5.6%
6/108 • Number of events 6 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
4.2%
56/1326 • Number of events 66 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
18.2%
8/44 • Number of events 10 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Proctitis
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Rectal perforation
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.36%
5/1378 • Number of events 6 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.23%
3/1326 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
40/1378 • Number of events 44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
6.5%
7/108 • Number of events 10 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
4.6%
5/108 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
3.1%
41/1326 • Number of events 45 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
9.1%
4/44 • Number of events 6 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
General disorders
Chest pain
|
0.36%
5/1378 • Number of events 6 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.45%
6/1326 • Number of events 6 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
General disorders
Edema limbs
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
General disorders
Fatigue
|
3.8%
53/1378 • Number of events 80 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.9%
2/108 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
8.3%
9/108 • Number of events 11 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
5.8%
77/1326 • Number of events 122 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
1/42 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
4.5%
2/44 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
General disorders
Flu-like symptoms
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
General disorders
Gait abnormal
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
General disorders
General symptom
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
General disorders
Ill-defined disorder
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
General disorders
Pain
|
0.29%
4/1378 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.38%
5/1326 • Number of events 6 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Abdominal infection
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Bladder infection
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.15%
2/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Catheter related infection
|
0.36%
5/1378 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.98%
13/1326 • Number of events 14 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
1/42 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Device related infection
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Ileal infection
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Infection
|
0.36%
5/1378 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.45%
6/1326 • Number of events 6 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Infectious colitis
|
0.58%
8/1378 • Number of events 10 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.38%
5/1326 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Joint infection
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Kidney infection
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Nail infection
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.23%
3/1326 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
1/42 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Otitis media
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Pneumonia
|
0.73%
10/1378 • Number of events 10 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.38%
5/1326 • Number of events 5 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Salivary gland infection
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Sepsis
|
0.29%
4/1378 • Number of events 4 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.45%
6/1326 • Number of events 6 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Skin infection
|
0.22%
3/1378 • Number of events 4 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
1.8%
24/1326 • Number of events 41 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
1/42 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.3%
1/44 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Upper aerodigestive tract infection
|
0.07%
1/1378 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Upper respiratory infection
|
0.22%
3/1378 • Number of events 3 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.38%
5/1326 • Number of events 6 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Urinary tract infection
|
0.29%
4/1378 • Number of events 4 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.60%
8/1326 • Number of events 8 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
2.4%
1/42 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Infections and infestations
Wound infection
|
0.15%
2/1378 • Number of events 2 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.08%
1/1326 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
|
Injury, poisoning and procedural complications
Arterial injury - Extremity-lower
|
0.00%
0/1378 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.93%
1/108 • Number of events 1 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/108 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/1326 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/42 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
0.00%
0/44 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
—
0/0 • 6 months or during treatment
All patients that received protocol treatment and completed at least one adverse event assessment are included in this analysis. Adverse event data was not collected for Arm G patients.
|
Additional Information
Dr. Steven Alberts
North Central Cancer Treatment Group
Phone: 507-284-8432
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60