Trial Outcomes & Findings for Paclitaxel With or Without Carboplatin and/or Bevacizumab Followed by Doxorubicin and Cyclophosphamide in Treating Patients With Breast Cancer That Can Be Removed by Surgery (NCT NCT00861705)
NCT ID: NCT00861705
Last Updated: 2025-09-30
Results Overview
Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain carboplatin (arms 3\&4) versus not (arms 1\&2) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
454 participants
Primary outcome timeframe
At the time of definitive surgical removal, up to 28 weeks
Results posted on
2025-09-30
Participant Flow
Participant milestones
| Measure |
Arm 1 (Pac --> ddAC)
Patients receive paclitaxel (pac) IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19.
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
cyclophosphamide: Given IV
|
Arm 2 (Pac + Bev --> ddAC + Bev)
Patients receive pac and ddAC as in arm 1. Patients also receive bevacizumab (bev) IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17.
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
cyclophosphamide: Given IV
bevacizumab: Given IV
|
Arm 3 (Pac + Carboplatin --> ddAC)
Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
cyclophosphamide: Given IV
carboplatin: Given IV
|
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)
Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
cyclophosphamide: Given IV
bevacizumab: Given IV
carboplatin: Given IV
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
115
|
113
|
113
|
113
|
|
Overall Study
COMPLETED
|
108
|
110
|
113
|
112
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
0
|
1
|
Reasons for withdrawal
| Measure |
Arm 1 (Pac --> ddAC)
Patients receive paclitaxel (pac) IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19.
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
cyclophosphamide: Given IV
|
Arm 2 (Pac + Bev --> ddAC + Bev)
Patients receive pac and ddAC as in arm 1. Patients also receive bevacizumab (bev) IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17.
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
cyclophosphamide: Given IV
bevacizumab: Given IV
|
Arm 3 (Pac + Carboplatin --> ddAC)
Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
cyclophosphamide: Given IV
carboplatin: Given IV
|
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)
Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
cyclophosphamide: Given IV
bevacizumab: Given IV
carboplatin: Given IV
|
|---|---|---|---|---|
|
Overall Study
Never Began Treatment
|
7
|
3
|
0
|
1
|
Baseline Characteristics
Paclitaxel With or Without Carboplatin and/or Bevacizumab Followed by Doxorubicin and Cyclophosphamide in Treating Patients With Breast Cancer That Can Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Arm 1 (Pac --> ddAC)
n=115 Participants
Patients receive paclitaxel (pac) IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19.
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
cyclophosphamide: Given IV
|
Arm 2 (Pac + Bev --> ddAC + Bev)
n=113 Participants
Patients receive pac and ddAC as in arm 1. Patients also receive bevacizumab (bev) IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17.
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
cyclophosphamide: Given IV
bevacizumab: Given IV
|
Arm 3 (Pac + Carboplatin --> ddAC)
n=113 Participants
Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
cyclophosphamide: Given IV
carboplatin: Given IV
|
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)
n=113 Participants
Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
cyclophosphamide: Given IV
bevacizumab: Given IV
carboplatin: Given IV
|
Total
n=454 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
50.2 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
50.9 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
49.1 years
STANDARD_DEVIATION 10.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
454 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
89 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
331 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At the time of definitive surgical removal, up to 28 weeksPopulation: All patients who began protocol neoadjuvant therapy and are assessable for pCR endpoint (N=433).
Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain carboplatin (arms 3\&4) versus not (arms 1\&2) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.
Outcome measures
| Measure |
Factor A: Carboplatin
n=221 Participants
Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 \& 4).
|
Factor A: No Carboplatin
n=212 Participants
Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 \& 2).
|
Arm 3 (Pac + Carboplatin --> ddAC)
Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.
doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV carboplatin: Given IV
|
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)
Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.
doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV bevacizumab: Given IV carboplatin: Given IV
|
|---|---|---|---|---|
|
Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).
|
60 percentage of participants with pCR
Interval 54.0 to 66.0
|
46 percentage of participants with pCR
Interval 40.0 to 53.0
|
—
|
—
|
PRIMARY outcome
Timeframe: At the time of definitive surgical removal, up to 28 weeksPopulation: All patients who began protocol neoadjuvant therapy and are assessable for pCR endpoint (N=433).
Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain bevacizumab (arms 2\&4) versus not (arms 1\&3) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.
Outcome measures
| Measure |
Factor A: Carboplatin
n=215 Participants
Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 \& 4).
|
Factor A: No Carboplatin
n=218 Participants
Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 \& 2).
|
Arm 3 (Pac + Carboplatin --> ddAC)
Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.
doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV carboplatin: Given IV
|
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)
Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.
doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV bevacizumab: Given IV carboplatin: Given IV
|
|---|---|---|---|---|
|
Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).
|
59 percentage of participants with pCR
Interval 52.0 to 65.0
|
48 percentage of participants with pCR
Interval 41.0 to 54.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At the time of definitive surgical removal, up to 28 weeksComparing regimens that contain carboplatin (arms 3\&4) versus not (arms 1\&2).
Outcome measures
| Measure |
Factor A: Carboplatin
n=221 Participants
Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 \& 4).
|
Factor A: No Carboplatin
n=212 Participants
Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 \& 2).
|
Arm 3 (Pac + Carboplatin --> ddAC)
Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.
doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV carboplatin: Given IV
|
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)
Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.
doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV bevacizumab: Given IV carboplatin: Given IV
|
|---|---|---|---|---|
|
Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0).
|
54 percentage of participants with pCR
Interval 48.0 to 61.0
|
41 percentage of participants with pCR
Interval 35.0 to 48.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At the time of definitive surgical removal, up to 28 weeksComparing regimens that contain bevacizumab (arms 2\&4) versus not (arms 1\&3).
Outcome measures
| Measure |
Factor A: Carboplatin
n=215 Participants
Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 \& 4).
|
Factor A: No Carboplatin
n=218 Participants
Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 \& 2).
|
Arm 3 (Pac + Carboplatin --> ddAC)
Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.
doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV carboplatin: Given IV
|
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)
Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.
doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV bevacizumab: Given IV carboplatin: Given IV
|
|---|---|---|---|---|
|
Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0).
|
52 percentage of participants with pCR
Interval 45.0 to 58.0
|
44 percentage of participants with pCR
Interval 38.0 to 51.0
|
—
|
—
|
SECONDARY outcome
Timeframe: at definitive surgery, up to 28 weeksStage II is (T2,T3, N0, M0) tumor size more than 2 cm but no deep extradermal structure invasion, no regional lymph node metastasis, and no distant metastasis. Stage III is (T4, N0, M0) tumor invasion of deep extradermal structures, no regional lymph node metasis, and no distant metasasis or (Any T, N1, M0) Any tumor size, regional lymph node metastasis, and no distant metastasis.
Outcome measures
| Measure |
Factor A: Carboplatin
n=107 Participants
Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 \& 4).
|
Factor A: No Carboplatin
n=105 Participants
Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 \& 2).
|
Arm 3 (Pac + Carboplatin --> ddAC)
n=111 Participants
Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.
doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV carboplatin: Given IV
|
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)
n=110 Participants
Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.
doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV bevacizumab: Given IV carboplatin: Given IV
|
|---|---|---|---|---|
|
Pathologic Stage in the Breast and in the Breast Plus Axilla as Measured by American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM) Staging Criteria (Version 6)
Breast : Stage II
|
42 participants
|
49 participants
|
51 participants
|
70 participants
|
|
Pathologic Stage in the Breast and in the Breast Plus Axilla as Measured by American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM) Staging Criteria (Version 6)
Breast : Stage III
|
42 participants
|
55 participants
|
57 participants
|
62 participants
|
|
Pathologic Stage in the Breast and in the Breast Plus Axilla as Measured by American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM) Staging Criteria (Version 6)
Breast/Axilla : Stage II
|
41 participants
|
42 participants
|
47 participants
|
63 participants
|
|
Pathologic Stage in the Breast and in the Breast Plus Axilla as Measured by American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM) Staging Criteria (Version 6)
Breast/Axilla : Stage III
|
36 participants
|
45 participants
|
51 participants
|
54 participants
|
SECONDARY outcome
Timeframe: Baseline; at completion of neoadjuvant therapyAssessed by RECIST, each patient will have a pre-therapy baseline radiographic tumor measurement, preferably by MRI, however if logistic or practical or financial issues preclude MRI use, mammogram or ultrasound may be substituted. The longest diameter (LD) of the target lesion at the time of study initiation will be reported as the baseline LD. The baseline LD of the target lesion will be used as reference to further characterize the objective tumor response of the measurable dimension of the disease. Radiographic complete response: Disappearance of the target lesion. Radiographic partial response (PR): At least a 30% decrease in the longest diameter (LD) of the target lesion taking as reference the baseline LD.
Outcome measures
| Measure |
Factor A: Carboplatin
n=108 Participants
Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 \& 4).
|
Factor A: No Carboplatin
n=110 Participants
Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 \& 2).
|
Arm 3 (Pac + Carboplatin --> ddAC)
n=112 Participants
Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.
doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV carboplatin: Given IV
|
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)
n=112 Participants
Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.
doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV bevacizumab: Given IV carboplatin: Given IV
|
|---|---|---|---|---|
|
Radiographic Response Assessed by Tumor Measurement
Complete Response
|
11 Participants
|
12 Participants
|
19 Participants
|
13 Participants
|
|
Radiographic Response Assessed by Tumor Measurement
Partial Response
|
16 Participants
|
11 Participants
|
16 Participants
|
17 Participants
|
|
Radiographic Response Assessed by Tumor Measurement
Failures
|
81 Participants
|
87 Participants
|
77 Participants
|
82 Participants
|
SECONDARY outcome
Timeframe: Baseline; at completion of neoadjuvant therapyAssessed by Response Evaluation Criteria in Solid Tumors (RECIST). Both target and, in the event of multifocal or multicentric invasive breast cancer, nontarget lesions should be followed clinically and their clinical size recorded at aseline. Measurements thereafter are required at the completion of 12 weeks of paclitaxel or paclitaxel/carboplatin and at the completion of all neoadjuvant chemotherapy. At any time point, these lesions should be categorized regarding whether there is evidence of progression. If "yes", the study chair should be notified in order to determine whether the patient should come off protocol treatment. In-situcarcinoma does not represent a non-target lesion and should not be recorded or followed.
Outcome measures
| Measure |
Factor A: Carboplatin
n=108 Participants
Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 \& 4).
|
Factor A: No Carboplatin
n=110 Participants
Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 \& 2).
|
Arm 3 (Pac + Carboplatin --> ddAC)
n=112 Participants
Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.
doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV carboplatin: Given IV
|
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)
n=112 Participants
Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.
doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV bevacizumab: Given IV carboplatin: Given IV
|
|---|---|---|---|---|
|
Clinical Response Assessed by Tumor Measurement
Complete Response
|
28 Participants
|
35 Participants
|
45 Participants
|
40 Participants
|
|
Clinical Response Assessed by Tumor Measurement
Partial Response
|
37 Participants
|
38 Participants
|
36 Participants
|
37 Participants
|
|
Clinical Response Assessed by Tumor Measurement
Failures
|
43 Participants
|
37 Participants
|
31 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: up to 10 yearsPopulation: All treated patients
Number of Participants who Died Due to Any Cause
Outcome measures
| Measure |
Factor A: Carboplatin
n=107 Participants
Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 \& 4).
|
Factor A: No Carboplatin
n=110 Participants
Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 \& 2).
|
Arm 3 (Pac + Carboplatin --> ddAC)
n=112 Participants
Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.
doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV carboplatin: Given IV
|
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)
n=112 Participants
Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.
doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV bevacizumab: Given IV carboplatin: Given IV
|
|---|---|---|---|---|
|
Overall Survival
|
22 Participants
|
26 Participants
|
30 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: up to 10 yearsFrom definitive surgery to first instance of ipsilateral invasive breast tumor recurrence, local/regional invasive breast cancer recurrence, distant recurrence, or death from any cause. Number of Participants who Died Due to Any Cause or had a recurrence.
Outcome measures
| Measure |
Factor A: Carboplatin
n=108 Participants
Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 \& 4).
|
Factor A: No Carboplatin
n=110 Participants
Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 \& 2).
|
Arm 3 (Pac + Carboplatin --> ddAC)
n=112 Participants
Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.
doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV carboplatin: Given IV
|
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)
n=112 Participants
Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.
doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV bevacizumab: Given IV carboplatin: Given IV
|
|---|---|---|---|---|
|
Recurrence-free Survival
With event
|
32 Participants
|
34 Participants
|
37 Participants
|
27 Participants
|
|
Recurrence-free Survival
Without event
|
76 Participants
|
76 Participants
|
75 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: up to 10 yearsFrom study entry to first event.
Outcome measures
| Measure |
Factor A: Carboplatin
n=108 Participants
Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 \& 4).
|
Factor A: No Carboplatin
n=110 Participants
Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 \& 2).
|
Arm 3 (Pac + Carboplatin --> ddAC)
n=112 Participants
Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.
doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV carboplatin: Given IV
|
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)
n=112 Participants
Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.
doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV bevacizumab: Given IV carboplatin: Given IV
|
|---|---|---|---|---|
|
Count of Participants With a First Failure, Defined as First Instance of Ipsilateral Invasive Breast Tumor Recurrence, Local/Regional Invasive Breast Cancer Recurrence, Distant Recurrence, or Death From Any Cause
With event
|
23 Participants
|
26 Participants
|
28 Participants
|
22 Participants
|
|
Count of Participants With a First Failure, Defined as First Instance of Ipsilateral Invasive Breast Tumor Recurrence, Local/Regional Invasive Breast Cancer Recurrence, Distant Recurrence, or Death From Any Cause
Without event
|
85 Participants
|
84 Participants
|
84 Participants
|
90 Participants
|
SECONDARY outcome
Timeframe: at definitive surgery, up to 28 weeksAssessed by physician observation.
Outcome measures
| Measure |
Factor A: Carboplatin
n=213 Participants
Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 \& 4).
|
Factor A: No Carboplatin
n=214 Participants
Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 \& 2).
|
Arm 3 (Pac + Carboplatin --> ddAC)
Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.
doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV carboplatin: Given IV
|
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)
Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.
doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV bevacizumab: Given IV carboplatin: Given IV
|
|---|---|---|---|---|
|
Incidence and Severity of Post-op Complications, Namely Excessive Bleeding, Delayed Wound Healing, and Wound Dehiscence.
Excessive bleeding
|
0 percentage of participants with event
Interval 0.0 to 2.0
|
0 percentage of participants with event
Interval 0.0 to 3.0
|
—
|
—
|
|
Incidence and Severity of Post-op Complications, Namely Excessive Bleeding, Delayed Wound Healing, and Wound Dehiscence.
Delayed healing
|
1 percentage of participants with event
Interval 0.0 to 3.0
|
0 percentage of participants with event
Interval 0.0 to 3.0
|
—
|
—
|
|
Incidence and Severity of Post-op Complications, Namely Excessive Bleeding, Delayed Wound Healing, and Wound Dehiscence.
Wound dehiscence
|
1 percentage of participants with event
Interval 1.0 to 4.0
|
0 percentage of participants with event
Interval 0.0 to 3.0
|
—
|
—
|
Adverse Events
Arm 1 (Pac --> ddAC)
Serious events: 15 serious events
Other events: 107 other events
Deaths: 0 deaths
Arm 2 (Pac + Bev --> ddAC + Bev)
Serious events: 27 serious events
Other events: 104 other events
Deaths: 0 deaths
Arm 3 (Pac + Carboplatin --> ddAC)
Serious events: 21 serious events
Other events: 106 other events
Deaths: 0 deaths
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)
Serious events: 39 serious events
Other events: 109 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1 (Pac --> ddAC)
n=108 participants at risk
cyclophosphamide: Given IV
|
Arm 2 (Pac + Bev --> ddAC + Bev)
n=108 participants at risk
bevacizumab: Given IV
|
Arm 3 (Pac + Carboplatin --> ddAC)
n=109 participants at risk
carboplatin: Given IV
|
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)
n=112 participants at risk
carboplatin: Given IV
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
10.2%
11/108 • Number of events 11
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
13.0%
14/108 • Number of events 17
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
15.6%
17/109 • Number of events 20
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
25.0%
28/112 • Number of events 33
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.7%
4/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
8.3%
9/109 • Number of events 9
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
13.4%
15/112 • Number of events 16
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/109 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.4%
6/112 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Cardiac disorders
Palpitations
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Eye disorders
Dry eye syndrome
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Eye disorders
Eye disorder
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Eye disorders
Vision blurred
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Eye disorders
Watering eyes
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/109 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.4%
6/112 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Anal mucositis
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Anal ulcer
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Constipation
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
8.3%
9/108 • Number of events 11
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/109 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
16.1%
18/112 • Number of events 19
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Diarrhea
|
3.7%
4/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.6%
6/108 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
6.4%
7/109 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
12.5%
14/112 • Number of events 15
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Dyspepsia
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/109 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.5%
5/112 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Dysphagia
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.1%
8/112 • Number of events 9
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.7%
3/112 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Ileal fistula
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Mucositis oral
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/109 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.1%
8/112 • Number of events 8
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Nausea
|
5.6%
6/108 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
12.0%
13/108 • Number of events 15
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
10.1%
11/109 • Number of events 12
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
18.8%
21/112 • Number of events 23
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Oesophagoscopy abnormal
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Rectal fistula
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.7%
3/112 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
6.5%
7/108 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/109 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
13.4%
15/112 • Number of events 16
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
General disorders
Chest pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
General disorders
Chills
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/109 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.7%
3/112 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
General disorders
Edema limbs
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
General disorders
Fatigue
|
11.1%
12/108 • Number of events 12
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
20.4%
22/108 • Number of events 25
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
17.4%
19/109 • Number of events 22
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
32.1%
36/112 • Number of events 41
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
General disorders
Fever
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/109 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.7%
3/112 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
General disorders
Flu-like symptoms
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
General disorders
General symptom
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
General disorders
Injection site reaction
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
General disorders
Localized edema
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
General disorders
Pain
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/109 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.5%
5/112 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Anal infection
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Bladder infection
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Catheter related infection
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Device related infection
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Esophageal infection
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Infection
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Joint infection
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Nail infection
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Pneumonia
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Sepsis
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Skin infection
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Tooth infection
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Upper respiratory infection
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.5%
5/112 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Uterine infection
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Wound infection
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Alanine aminotransferase increased
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/109 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
8.0%
9/112 • Number of events 9
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/109 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.4%
6/112 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Amylase increased
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Aspartate aminotransferase increased
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/109 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.1%
8/112 • Number of events 8
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Cardiac troponin T increased
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Creatinine increased
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/109 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Haptoglobin decreased
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
INR increased
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Laboratory test abnormal
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.7%
3/112 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Leukocyte count decreased
|
5.6%
6/108 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.6%
6/108 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
11.9%
13/109 • Number of events 15
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
12.5%
14/112 • Number of events 15
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Lipase increased
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Lymphocyte count decreased
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/109 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
6.2%
7/112 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Neutrophil count decreased
|
6.5%
7/108 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
11.1%
12/108 • Number of events 15
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
14.7%
16/109 • Number of events 18
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
19.6%
22/112 • Number of events 26
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Platelet count decreased
|
5.6%
6/108 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.4%
8/108 • Number of events 10
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
14.7%
16/109 • Number of events 18
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
18.8%
21/112 • Number of events 25
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Weight loss
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.5%
5/112 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Anorexia
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.6%
6/108 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.3%
8/109 • Number of events 10
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
9.8%
11/112 • Number of events 12
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
4.6%
5/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/108 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
6.4%
7/109 • Number of events 8
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
8.9%
10/112 • Number of events 11
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/109 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.1%
8/112 • Number of events 8
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/109 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
8.0%
9/112 • Number of events 10
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
3.7%
4/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/108 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/109 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.1%
8/112 • Number of events 9
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/109 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
6.2%
7/112 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.6%
6/108 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
6.4%
7/109 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
6.2%
7/112 • Number of events 8
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/109 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
8.9%
10/112 • Number of events 11
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.7%
3/112 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Abdominal soft tissue necrosis
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.6%
4/112 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.5%
5/112 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.6%
4/112 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Ataxia
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Dizziness
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/109 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.4%
6/112 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Dysgeusia
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/109 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.6%
4/112 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Headache
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.4%
8/108 • Number of events 8
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.5%
6/109 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
6.2%
7/112 • Number of events 9
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Neurological disorder NOS
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/109 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.7%
3/112 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.4%
8/108 • Number of events 8
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
13.9%
15/108 • Number of events 17
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
11.9%
13/109 • Number of events 16
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
16.1%
18/112 • Number of events 21
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Syncope
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Tremor
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Psychiatric disorders
Agitation
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Psychiatric disorders
Anxiety
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.1%
8/112 • Number of events 8
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Psychiatric disorders
Confusion
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Psychiatric disorders
Depression
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.4%
6/112 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Psychiatric disorders
Insomnia
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/109 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.6%
4/112 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Renal and urinary disorders
Hemoglobin urine positive
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Renal and urinary disorders
Proteinuria
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.7%
3/112 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Reproductive system and breast disorders
Reproductive tract disorder
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/109 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
4/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.6%
6/108 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/109 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
8.0%
9/112 • Number of events 9
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
9.3%
10/108 • Number of events 10
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
6.4%
7/109 • Number of events 8
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
12.5%
14/112 • Number of events 15
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.6%
6/108 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.1%
8/112 • Number of events 8
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.7%
4/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.4%
8/108 • Number of events 9
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
11.0%
12/109 • Number of events 14
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
16.1%
18/112 • Number of events 19
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.6%
4/112 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.4%
8/108 • Number of events 8
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/109 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.5%
5/112 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Vascular disorders
Hot flashes
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Vascular disorders
Hypertension
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.6%
6/108 • Number of events 8
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
9.8%
11/112 • Number of events 11
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Vascular disorders
Hypotension
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.7%
3/112 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Vascular disorders
Thrombosis
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
Other adverse events
| Measure |
Arm 1 (Pac --> ddAC)
n=108 participants at risk
cyclophosphamide: Given IV
|
Arm 2 (Pac + Bev --> ddAC + Bev)
n=108 participants at risk
bevacizumab: Given IV
|
Arm 3 (Pac + Carboplatin --> ddAC)
n=109 participants at risk
carboplatin: Given IV
|
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)
n=112 participants at risk
carboplatin: Given IV
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
69.4%
75/108 • Number of events 196
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
59.3%
64/108 • Number of events 148
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
82.6%
90/109 • Number of events 277
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
82.1%
92/112 • Number of events 255
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.4%
8/108 • Number of events 9
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/109 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
9.8%
11/112 • Number of events 11
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
8.3%
9/108 • Number of events 20
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
15.7%
17/108 • Number of events 30
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
10.1%
11/109 • Number of events 22
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
10.7%
12/112 • Number of events 31
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Blood and lymphatic system disorders
Hemolysis
|
2.8%
3/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Cardiac disorders
Cardiac pain
|
1.9%
2/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Cardiac disorders
Left ventricular failure
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Cardiac disorders
Palpitations
|
3.7%
4/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.4%
8/108 • Number of events 10
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.3%
8/109 • Number of events 10
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.6%
4/112 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Cardiac disorders
Sinus tachycardia
|
1.9%
2/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/109 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.4%
6/112 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Cardiac disorders
Stokes-Adams syndrome
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Ear and labyrinth disorders
Ear pain
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Endocrine disorders
Hypothyroidism
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Eye disorders
Diplopia
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Eye disorders
Dry eye syndrome
|
3.7%
4/108 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.5%
5/112 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Eye disorders
Eye disorder
|
3.7%
4/108 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/108 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Eye disorders
Eye pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Eye disorders
Flashing vision
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Eye disorders
Keratitis
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Eye disorders
Photophobia
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Eye disorders
Vision blurred
|
13.0%
14/108 • Number of events 23
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
9.3%
10/108 • Number of events 16
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/109 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
11.6%
13/112 • Number of events 24
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Eye disorders
Watering eyes
|
8.3%
9/108 • Number of events 10
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
13.9%
15/108 • Number of events 21
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.3%
8/109 • Number of events 9
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
6.2%
7/112 • Number of events 14
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.93%
1/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Abdominal pain
|
13.0%
14/108 • Number of events 15
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/108 • Number of events 8
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.3%
8/109 • Number of events 13
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
13.4%
15/112 • Number of events 24
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Anal exam abnormal
|
0.93%
1/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Anal mucositis
|
0.93%
1/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Constipation
|
43.5%
47/108 • Number of events 91
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
48.1%
52/108 • Number of events 103
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
43.1%
47/109 • Number of events 88
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
54.5%
61/112 • Number of events 117
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
36/108 • Number of events 60
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
34.3%
37/108 • Number of events 57
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
30.3%
33/109 • Number of events 52
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
31.2%
35/112 • Number of events 57
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Dry mouth
|
4.6%
5/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/108 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.7%
3/112 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Dyspepsia
|
25.9%
28/108 • Number of events 43
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
20.4%
22/108 • Number of events 37
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
27.5%
30/109 • Number of events 40
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
26.8%
30/112 • Number of events 51
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Dysphagia
|
1.9%
2/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/109 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.7%
3/112 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
10.2%
11/108 • Number of events 16
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
11.1%
12/108 • Number of events 19
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
12.8%
14/109 • Number of events 16
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
19.6%
22/112 • Number of events 34
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Esophageal mucositis
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Esophageal stenosis
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Esophagitis
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.7%
3/112 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Fistula of small intestine
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Flatulence
|
3.7%
4/108 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Gastritis
|
3.7%
4/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.6%
4/112 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/109 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.7%
3/112 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.8%
3/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
6.5%
7/108 • Number of events 9
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/109 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
8.0%
9/112 • Number of events 12
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Mucositis oral
|
20.4%
22/108 • Number of events 37
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
31.5%
34/108 • Number of events 64
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
21.1%
23/109 • Number of events 42
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
26.8%
30/112 • Number of events 52
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Nausea
|
72.2%
78/108 • Number of events 158
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
67.6%
73/108 • Number of events 148
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
67.9%
74/109 • Number of events 173
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
79.5%
89/112 • Number of events 202
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Oesophagoscopy abnormal
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Oral pain
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/109 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.6%
4/112 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Periodontal disease
|
0.93%
1/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Rectal fistula
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.6%
4/112 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Salivary gland disorder
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Stomach pain
|
3.7%
4/108 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
27/108 • Number of events 37
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
25.9%
28/108 • Number of events 37
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
29.4%
32/109 • Number of events 57
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
27.7%
31/112 • Number of events 46
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
General disorders
Chest pain
|
3.7%
4/108 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/108 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
General disorders
Chills
|
11.1%
12/108 • Number of events 14
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.4%
8/108 • Number of events 9
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/109 • Number of events 10
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
8.9%
10/112 • Number of events 12
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
General disorders
Edema limbs
|
18.5%
20/108 • Number of events 38
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
11.1%
12/108 • Number of events 15
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
11.0%
12/109 • Number of events 19
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
6.2%
7/112 • Number of events 13
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
General disorders
Facial pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
General disorders
Fatigue
|
88.9%
96/108 • Number of events 302
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
89.8%
97/108 • Number of events 296
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
89.0%
97/109 • Number of events 293
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
90.2%
101/112 • Number of events 299
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
General disorders
Fever
|
12.0%
13/108 • Number of events 13
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
13.0%
14/108 • Number of events 14
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.3%
8/109 • Number of events 9
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
8.9%
10/112 • Number of events 13
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
General disorders
Flu-like symptoms
|
3.7%
4/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
General disorders
Gait abnormal
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
General disorders
General symptom
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
General disorders
Ill-defined disorder
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
General disorders
Injection site reaction
|
1.9%
2/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
General disorders
Localized edema
|
4.6%
5/108 • Number of events 8
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
General disorders
Pain
|
15.7%
17/108 • Number of events 32
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
18.5%
20/108 • Number of events 35
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
11.9%
13/109 • Number of events 20
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
16.1%
18/112 • Number of events 22
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
General disorders
Visceral edema
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Hepatobiliary disorders
Hepatic hemorrhage
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Immune system disorders
Autoimmune disorder
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Immune system disorders
Hypersensitivity
|
7.4%
8/108 • Number of events 8
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
10.2%
11/108 • Number of events 12
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.5%
6/109 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
10.7%
12/112 • Number of events 13
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Immune system disorders
Immune system disorder
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Anal infection
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Bladder infection
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Bone infection
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Bronchitis
|
1.9%
2/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Conjunctivitis infective
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Device related infection
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Esophageal infection
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Eye infection
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Gingival infection
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Infection
|
3.7%
4/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.5%
6/109 • Number of events 9
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.6%
4/112 • Number of events 8
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Infective myositis
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Laryngitis
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Lip infection
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Mucosal infection
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Nail infection
|
5.6%
6/108 • Number of events 8
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
6.5%
7/108 • Number of events 8
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.6%
4/112 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Otitis externa
|
0.93%
1/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Otitis media
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Paranasal sinus infection
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Pharyngitis
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Sinusitis
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/109 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Skin infection
|
5.6%
6/108 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
10.2%
11/108 • Number of events 14
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/109 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.6%
4/112 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Soft tissue infection
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Tooth infection
|
1.9%
2/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/108 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Upper aerodigestive tract infection
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Upper respiratory infection
|
4.6%
5/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.4%
8/108 • Number of events 10
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.5%
6/109 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.1%
8/112 • Number of events 9
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Ureteritis
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Urinary tract infection
|
8.3%
9/108 • Number of events 11
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
6.5%
7/108 • Number of events 10
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
8.9%
10/112 • Number of events 11
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Vaginal infection
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Viral hepatitis
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Vulvitis
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Infections and infestations
Wound infection
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.7%
3/112 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Injury, poisoning and procedural complications
Bruising
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.5%
5/112 • Number of events 8
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Injury, poisoning and procedural complications
Intraoperative gastrointestinal injury - Teeth
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
0.93%
1/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Injury, poisoning and procedural complications
Seroma
|
0.93%
1/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
6.5%
7/108 • Number of events 12
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/109 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.1%
8/112 • Number of events 9
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Alanine aminotransferase increased
|
17.6%
19/108 • Number of events 27
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
25.0%
27/108 • Number of events 45
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
20.2%
22/109 • Number of events 43
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
32.1%
36/112 • Number of events 55
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Alkaline phosphatase increased
|
12.0%
13/108 • Number of events 24
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
9.3%
10/108 • Number of events 13
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.3%
8/109 • Number of events 16
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
15.2%
17/112 • Number of events 34
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Aspartate aminotransferase increased
|
18.5%
20/108 • Number of events 36
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
25.0%
27/108 • Number of events 41
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
16.5%
18/109 • Number of events 34
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
25.9%
29/112 • Number of events 44
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.5%
5/112 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Coagulopathy
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Creatinine increased
|
4.6%
5/108 • Number of events 9
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/109 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.6%
4/112 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Electrocardiogram QTc interval prolonged
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
INR increased
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Laboratory test abnormal
|
4.6%
5/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/108 • Number of events 10
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/109 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.1%
8/112 • Number of events 12
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Leukocyte count decreased
|
21.3%
23/108 • Number of events 45
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
28.7%
31/108 • Number of events 55
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
36.7%
40/109 • Number of events 77
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
34.8%
39/112 • Number of events 81
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Lymphocyte count decreased
|
11.1%
12/108 • Number of events 15
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
10.2%
11/108 • Number of events 19
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.3%
8/109 • Number of events 11
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
15.2%
17/112 • Number of events 30
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Neutrophil count decreased
|
32.4%
35/108 • Number of events 58
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
37.0%
40/108 • Number of events 62
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
78.0%
85/109 • Number of events 173
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
80.4%
90/112 • Number of events 185
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Platelet count decreased
|
16.7%
18/108 • Number of events 26
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
17.6%
19/108 • Number of events 29
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
61.5%
67/109 • Number of events 154
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
68.8%
77/112 • Number of events 156
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Serum cholesterol increased
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Weight gain
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Investigations
Weight loss
|
9.3%
10/108 • Number of events 12
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
9.3%
10/108 • Number of events 12
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
10.1%
11/109 • Number of events 16
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
16.1%
18/112 • Number of events 23
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Anorexia
|
25.9%
28/108 • Number of events 48
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
32.4%
35/108 • Number of events 61
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
30.3%
33/109 • Number of events 58
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
39.3%
44/112 • Number of events 75
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.7%
3/112 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
28.7%
31/108 • Number of events 59
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
25.9%
28/108 • Number of events 49
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
23.9%
26/109 • Number of events 57
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
25.9%
29/112 • Number of events 57
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
6/108 • Number of events 8
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.4%
8/108 • Number of events 12
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
9.2%
10/109 • Number of events 11
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
9.8%
11/112 • Number of events 13
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
8.3%
9/108 • Number of events 15
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
6.5%
7/108 • Number of events 12
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.5%
6/109 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
12.5%
14/112 • Number of events 21
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
12.0%
13/108 • Number of events 18
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
11.1%
12/108 • Number of events 14
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
9.2%
10/109 • Number of events 13
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
8.0%
9/112 • Number of events 12
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.6%
4/112 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
10.1%
11/109 • Number of events 20
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
15.7%
17/108 • Number of events 25
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
13.9%
15/108 • Number of events 21
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
25.7%
28/109 • Number of events 57
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
18.8%
21/112 • Number of events 32
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.7%
3/112 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
8.3%
9/108 • Number of events 17
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
11.1%
12/108 • Number of events 20
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
10.1%
11/109 • Number of events 19
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
14.3%
16/112 • Number of events 18
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.2%
24/108 • Number of events 47
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
21.3%
23/108 • Number of events 39
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
14.7%
16/109 • Number of events 21
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
22.3%
25/112 • Number of events 41
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.93%
1/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.2%
11/108 • Number of events 13
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
10.2%
11/108 • Number of events 15
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
13.8%
15/109 • Number of events 19
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
15.2%
17/112 • Number of events 22
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
18/108 • Number of events 21
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
13.0%
14/108 • Number of events 22
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.3%
8/109 • Number of events 10
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
14.3%
16/112 • Number of events 28
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.6%
6/108 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/109 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.7%
3/112 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
3.7%
4/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.3%
8/109 • Number of events 12
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
1.9%
2/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.6%
6/108 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/109 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
36/108 • Number of events 58
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
18.5%
20/108 • Number of events 36
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
15.6%
17/109 • Number of events 24
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
22.3%
25/112 • Number of events 48
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.9%
2/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/109 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.9%
15/108 • Number of events 22
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
13.0%
14/108 • Number of events 20
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
9.2%
10/109 • Number of events 13
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
8.0%
9/112 • Number of events 10
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Musculoskeletal and connective tissue disorders
Upper extremity dysfunction
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor flare
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.93%
1/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Arachnoiditis
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Ataxia
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Cognitive disturbance
|
2.8%
3/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.7%
3/112 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Depressed level of consciousness
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Dizziness
|
23.1%
25/108 • Number of events 40
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
18.5%
20/108 • Number of events 35
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
20.2%
22/109 • Number of events 31
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
17.9%
20/112 • Number of events 27
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Dysgeusia
|
27.8%
30/108 • Number of events 56
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
20.4%
22/108 • Number of events 43
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
23.9%
26/109 • Number of events 48
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
30.4%
34/112 • Number of events 73
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Facial muscle weakness
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Headache
|
36.1%
39/108 • Number of events 75
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
41.7%
45/108 • Number of events 77
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
29.4%
32/109 • Number of events 50
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
38.4%
43/112 • Number of events 80
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Hypoglossal nerve disorder
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Memory impairment
|
2.8%
3/108 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Mini mental status examination abnormal
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Neurological disorder NOS
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.6%
4/112 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Olfactory nerve disorder
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.5%
7/108 • Number of events 13
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
9.3%
10/108 • Number of events 16
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
11.0%
12/109 • Number of events 22
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
10.7%
12/112 • Number of events 18
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
74.1%
80/108 • Number of events 221
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
75.9%
82/108 • Number of events 199
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
67.9%
74/109 • Number of events 195
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
74.1%
83/112 • Number of events 178
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Seizure
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Sinus pain
|
0.93%
1/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Syncope
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Nervous system disorders
Tremor
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Psychiatric disorders
Agitation
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.4%
6/112 • Number of events 10
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Psychiatric disorders
Anxiety
|
24.1%
26/108 • Number of events 46
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
16.7%
18/108 • Number of events 34
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
13.8%
15/109 • Number of events 22
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
19.6%
22/112 • Number of events 38
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Psychiatric disorders
Confusion
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Psychiatric disorders
Depression
|
18.5%
20/108 • Number of events 35
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
12.0%
13/108 • Number of events 26
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
16.5%
18/109 • Number of events 23
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
15.2%
17/112 • Number of events 28
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Psychiatric disorders
Insomnia
|
31.5%
34/108 • Number of events 72
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
29.6%
32/108 • Number of events 53
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
19.3%
21/109 • Number of events 37
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
26.8%
30/112 • Number of events 57
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 11
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Psychiatric disorders
Personality change
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Renal and urinary disorders
Bladder hemorrhage
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Renal and urinary disorders
Bladder pain
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Renal and urinary disorders
Cystitis
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.6%
4/112 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Renal and urinary disorders
Hemoglobin urine positive
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.5%
5/112 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Renal and urinary disorders
Kidney pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
6.5%
7/108 • Number of events 14
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
11.6%
13/112 • Number of events 18
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Renal and urinary disorders
Ureteric hemorrhage
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Renal and urinary disorders
Urinary frequency
|
4.6%
5/108 • Number of events 8
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/109 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
6.2%
7/112 • Number of events 10
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/108 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Renal and urinary disorders
Urogenital disorder
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.6%
4/112 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Reproductive system and breast disorders
Breast pain
|
9.3%
10/108 • Number of events 15
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.6%
6/108 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.5%
6/109 • Number of events 10
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.5%
5/112 • Number of events 8
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Reproductive system and breast disorders
Irregular menstruation
|
1.9%
2/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/109 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.4%
6/112 • Number of events 10
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Reproductive system and breast disorders
Nipple deformity
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Reproductive system and breast disorders
Reproductive tract disorder
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Reproductive system and breast disorders
Vaginal dryness
|
1.9%
2/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/108 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/108 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.7%
3/112 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
8.3%
9/108 • Number of events 14
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
14.8%
16/108 • Number of events 25
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.3%
8/109 • Number of events 11
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
13.4%
15/112 • Number of events 24
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.7%
31/108 • Number of events 46
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
28.7%
31/108 • Number of events 61
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
20.2%
22/109 • Number of events 31
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
28.6%
32/112 • Number of events 49
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
35.2%
38/108 • Number of events 63
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
36.1%
39/108 • Number of events 74
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
41.3%
45/109 • Number of events 84
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
42.9%
48/112 • Number of events 93
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.3%
10/108 • Number of events 15
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
52.8%
57/108 • Number of events 114
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
16.5%
18/109 • Number of events 22
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
51.8%
58/112 • Number of events 97
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngoscopy abnormal
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.8%
3/108 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
13.0%
14/108 • Number of events 23
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/109 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
8.0%
9/112 • Number of events 10
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.93%
1/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
7.4%
8/108 • Number of events 11
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
14.8%
16/108 • Number of events 19
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.5%
6/109 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
8.9%
10/112 • Number of events 16
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
3.7%
4/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
8.3%
9/108 • Number of events 13
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.5%
6/109 • Number of events 8
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.1%
8/112 • Number of events 11
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
4.6%
5/108 • Number of events 8
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
13.0%
14/108 • Number of events 18
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/109 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
11.6%
13/112 • Number of events 25
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
65.7%
71/108 • Number of events 204
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
54.6%
59/108 • Number of events 162
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
50.5%
55/109 • Number of events 136
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
54.5%
61/112 • Number of events 159
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
12/108 • Number of events 18
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
16.7%
18/108 • Number of events 26
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
8.3%
9/109 • Number of events 13
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
8.9%
10/112 • Number of events 20
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.9%
2/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/108 • Number of events 6
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
5.6%
6/108 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/109 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.7%
3/112 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
33.3%
36/108 • Number of events 73
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
35.2%
38/108 • Number of events 74
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
24.8%
27/109 • Number of events 37
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
24.1%
27/112 • Number of events 43
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.8%
16/108 • Number of events 22
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
12.0%
13/108 • Number of events 23
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.3%
8/109 • Number of events 9
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
10.7%
12/112 • Number of events 16
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
10.2%
11/108 • Number of events 21
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
9.3%
10/108 • Number of events 24
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.3%
8/109 • Number of events 14
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
8.0%
9/112 • Number of events 10
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
24.1%
26/108 • Number of events 45
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
27.8%
30/108 • Number of events 53
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
14.7%
16/109 • Number of events 22
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
17.0%
19/112 • Number of events 29
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
2.8%
3/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
5.6%
6/108 • Number of events 10
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.4%
8/108 • Number of events 9
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
6.4%
7/109 • Number of events 9
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
9.8%
11/112 • Number of events 14
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.9%
2/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
9.3%
10/108 • Number of events 16
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
4.6%
5/109 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.1%
8/112 • Number of events 16
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.93%
1/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Skin striae
|
2.8%
3/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Sweating
|
16.7%
18/108 • Number of events 33
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
3.7%
4/108 • Number of events 7
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
5.4%
6/112 • Number of events 9
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Vascular disorders
Flushing
|
1.9%
2/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
7.4%
8/108 • Number of events 10
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Vascular disorders
Hematoma
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Vascular disorders
Hemorrhage
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/112 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Vascular disorders
Hot flashes
|
29.6%
32/108 • Number of events 82
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
21.3%
23/108 • Number of events 57
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
18.3%
20/109 • Number of events 38
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
17.0%
19/112 • Number of events 40
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Vascular disorders
Hypertension
|
21.3%
23/108 • Number of events 46
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
35.2%
38/108 • Number of events 82
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
10.1%
11/109 • Number of events 16
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
44.6%
50/112 • Number of events 90
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Vascular disorders
Hypotension
|
2.8%
3/108 • Number of events 5
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.8%
3/108 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.8%
2/109 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
2.7%
3/112 • Number of events 4
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Vascular disorders
Lymphedema
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Vascular disorders
Phlebitis
|
0.93%
1/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.93%
1/108 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/112
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Vascular disorders
Thrombosis
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 2
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.92%
1/109 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
|
Vascular disorders
Vascular disorder
|
0.00%
0/108
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
1.9%
2/108 • Number of events 3
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.00%
0/109
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
0.89%
1/112 • Number of events 1
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
|
Additional Information
William M. Sikov, M.D.
Warren Alpert Medical School of Brown University, Department of Medicine
Phone: 401-793-7151
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60