Trial Outcomes & Findings for Pemetrexed Disodium, Carboplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III Non-Small Cell Lung Cancer (NCT NCT00117962)
NCT ID: NCT00117962
Last Updated: 2016-10-07
Results Overview
Percentage of participants who were alive at 18 months. The 18 month survival, with 95% CI, was estimated using the Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
109 participants
Primary outcome timeframe
18 months (from randomization)
Results posted on
2016-10-07
Participant Flow
Between September 2005 and January 2008, 109 participants were recruited.
Six (6) participants cancelled before receiving any protocol related therapy and 2 participants were deemed ineligible; therefore, 101 participants were analyzed.
Participant milestones
| Measure |
Std Tx + Pemetrexed
Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
|
Std Tx + Pemetrexed and Cetuximab
Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
53
|
|
Overall Study
COMPLETED
|
26
|
28
|
|
Overall Study
NOT COMPLETED
|
22
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pemetrexed Disodium, Carboplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Std Tx + Pemetrexed
n=48 Participants
Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
|
Std Tx + Pemetrexed and Cetuximab
n=53 Participants
Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
n=93 Participants
|
66 years
n=4 Participants
|
66 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=93 Participants
|
53 participants
n=4 Participants
|
101 participants
n=27 Participants
|
|
Histology
Adenocarcinoma
|
22 participants
n=93 Participants
|
22 participants
n=4 Participants
|
44 participants
n=27 Participants
|
|
Histology
Squamous
|
17 participants
n=93 Participants
|
18 participants
n=4 Participants
|
35 participants
n=27 Participants
|
|
Histology
NSCLC, undifferentiated
|
8 participants
n=93 Participants
|
10 participants
n=4 Participants
|
18 participants
n=27 Participants
|
|
Histology
Large cell
|
0 participants
n=93 Participants
|
2 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Histology
Not reported
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
ECOG Performance Status
0 - Fully Active
|
28 participants
n=93 Participants
|
18 participants
n=4 Participants
|
46 participants
n=27 Participants
|
|
ECOG Performance Status
1 - Ambulatory, restricted strenuous activity
|
20 participants
n=93 Participants
|
35 participants
n=4 Participants
|
55 participants
n=27 Participants
|
|
TNM Stage
IIIA
|
29 participants
n=93 Participants
|
27 participants
n=4 Participants
|
56 participants
n=27 Participants
|
|
TNM Stage
IIIB
|
18 participants
n=93 Participants
|
24 participants
n=4 Participants
|
42 participants
n=27 Participants
|
|
TNM Stage
Not reported
|
1 participants
n=93 Participants
|
2 participants
n=4 Participants
|
3 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 18 months (from randomization)Percentage of participants who were alive at 18 months. The 18 month survival, with 95% CI, was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Std Tx + Pemetrexed
n=48 Participants
Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
|
Std Tx + Pemetrexed and Cetuximab
n=53 Participants
Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
|
|---|---|---|
|
18 Month Survival
|
58 percentage of participants
Interval 46.0 to 74.0
|
54 percentage of participants
Interval 42.0 to 70.0
|
SECONDARY outcome
Timeframe: Time from randomization to failure (up to 4 years)Failure-free survival (FFS) is the time from randomization to a failure event, defined as disease progression or death from any cause (which ever occurred first). The median FFS with 95% CI was estimated using the Kaplan-Meier method,
Outcome measures
| Measure |
Std Tx + Pemetrexed
n=48 Participants
Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
|
Std Tx + Pemetrexed and Cetuximab
n=53 Participants
Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
|
|---|---|---|
|
Failure-free Survival
|
12.6 months
Interval 7.9 to 17.2
|
12.3 months
Interval 8.8 to 18.7
|
SECONDARY outcome
Timeframe: Duration of study until progression (up to 4 years)Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: * Complete Response (CR): disappearance of all target lesions; * Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; * Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; * Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs.
Outcome measures
| Measure |
Std Tx + Pemetrexed
n=48 Participants
Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
|
Std Tx + Pemetrexed and Cetuximab
n=53 Participants
Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
|
|---|---|---|
|
Number of Participants With Overall Tumor Response
|
37 participants
|
38 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time from randomization to death (up to 4 years)Overall survival (OS) is defined as the time from patient randomization (arm assignment) to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Std Tx + Pemetrexed
n=48 Participants
Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
|
Std Tx + Pemetrexed and Cetuximab
n=53 Participants
Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
|
|---|---|---|
|
Overall Survival
|
21.2 months
Interval 17.5 to
The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment
|
25.2 months
Interval 14.4 to
The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment
|
Adverse Events
Std Tx + Pemetrexed
Serious events: 21 serious events
Other events: 48 other events
Deaths: 0 deaths
Std Tx + Pemetrexed and Cetuximab
Serious events: 25 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Std Tx + Pemetrexed
n=50 participants at risk
Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
|
Std Tx + Pemetrexed and Cetuximab
n=53 participants at risk
Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.0%
3/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
28.0%
14/50 • Number of events 20
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
22.6%
12/53 • Number of events 16
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Cardiac disorders
Atrial fibrillation
|
4.0%
2/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
5.7%
3/53 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Cardiac disorders
Atrial tachycardia
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Cardiac disorders
Myocardial ischemia
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Cardiac disorders
Pericarditis
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Cardiac disorders
Sinus tachycardia
|
4.0%
2/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Cardiac disorders
Ventricular fibrillation
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Eye disorders
Vision blurred
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Constipation
|
6.0%
3/50 • Number of events 6
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
5/50 • Number of events 5
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
9.4%
5/53 • Number of events 6
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Dyspepsia
|
4.0%
2/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Dysphagia
|
16.0%
8/50 • Number of events 13
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
26.4%
14/53 • Number of events 19
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Esophageal mucositis
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Esophageal pain
|
8.0%
4/50 • Number of events 5
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Esophageal stenosis
|
4.0%
2/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Esophagitis
|
14.0%
7/50 • Number of events 10
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
15.1%
8/53 • Number of events 10
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Malabsorption
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Mucositis oral
|
6.0%
3/50 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Nausea
|
18.0%
9/50 • Number of events 13
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
11.3%
6/53 • Number of events 7
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Oral pain
|
2.0%
1/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Proctoscopy abnormal
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
6/50 • Number of events 9
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
9.4%
5/53 • Number of events 6
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
General disorders
Chest pain
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
5.7%
3/53 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
General disorders
Chills
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
General disorders
Death NOS
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
General disorders
Edema limbs
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
General disorders
Fatigue
|
34.0%
17/50 • Number of events 27
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
28.3%
15/53 • Number of events 20
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
General disorders
Fever
|
10.0%
5/50 • Number of events 5
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
General disorders
General symptom
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
General disorders
Localized edema
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
General disorders
Pain
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Immune system disorders
Hypersensitivity
|
2.0%
1/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
5.7%
3/53 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Infections and infestations
Bladder infection
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Infections and infestations
Infection
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Infections and infestations
Phlebitis infective
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Infections and infestations
Pneumonia
|
10.0%
5/50 • Number of events 5
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
5.7%
3/53 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Infections and infestations
Sinusitis
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Infections and infestations
Small intestine infection
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Alanine aminotransferase increased
|
6.0%
3/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
9.4%
5/53 • Number of events 6
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Alkaline phosphatase increased
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Aspartate aminotransferase increased
|
8.0%
4/50 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
9.4%
5/53 • Number of events 5
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Blood bilirubin increased
|
6.0%
3/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
5.7%
3/53 • Number of events 6
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Creatinine increased
|
8.0%
4/50 • Number of events 5
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
INR increased
|
4.0%
2/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Laboratory test abnormal
|
6.0%
3/50 • Number of events 5
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Leukocyte count decreased
|
28.0%
14/50 • Number of events 20
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
34.0%
18/53 • Number of events 27
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Lymphocyte count decreased
|
6.0%
3/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
9.4%
5/53 • Number of events 9
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Neutrophil count decreased
|
22.0%
11/50 • Number of events 15
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
26.4%
14/53 • Number of events 21
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Platelet count decreased
|
28.0%
14/50 • Number of events 18
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
32.1%
17/53 • Number of events 26
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Serum cholesterol increased
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Weight loss
|
8.0%
4/50 • Number of events 8
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
7.5%
4/53 • Number of events 5
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Anorexia
|
12.0%
6/50 • Number of events 9
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
18.9%
10/53 • Number of events 11
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
16.0%
8/50 • Number of events 10
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
15.1%
8/53 • Number of events 10
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Dehydration
|
18.0%
9/50 • Number of events 11
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
17.0%
9/53 • Number of events 10
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
14.0%
7/50 • Number of events 8
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
11.3%
6/53 • Number of events 7
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
10.0%
5/50 • Number of events 5
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
9.4%
5/53 • Number of events 9
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
10.0%
5/50 • Number of events 6
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
5.7%
3/53 • Number of events 7
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
4.0%
2/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
6.0%
3/50 • Number of events 5
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
15.1%
8/53 • Number of events 13
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
4.0%
2/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
7.5%
4/53 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Nervous system disorders
Dizziness
|
4.0%
2/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
9.4%
5/53 • Number of events 5
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Nervous system disorders
Dysgeusia
|
2.0%
1/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Nervous system disorders
Extrapyramidal disorder
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Nervous system disorders
Headache
|
8.0%
4/50 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.0%
2/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Nervous system disorders
Seizure
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Nervous system disorders
Syncope
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Psychiatric disorders
Confusion
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Psychiatric disorders
Depression
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
5.7%
3/53 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Renal and urinary disorders
Bladder hemorrhage
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Renal and urinary disorders
Urinary frequency
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Renal and urinary disorders
Urogenital disorder
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.0%
7/50 • Number of events 8
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
13.2%
7/53 • Number of events 8
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
10/50 • Number of events 12
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
13.2%
7/53 • Number of events 8
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.0%
3/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
5/50 • Number of events 5
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
11.3%
6/53 • Number of events 6
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
4.0%
2/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.0%
2/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.0%
1/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
18.9%
10/53 • Number of events 15
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
11.3%
6/53 • Number of events 6
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Vascular disorders
Hypertension
|
4.0%
2/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Vascular disorders
Hypotension
|
10.0%
5/50 • Number of events 5
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
11.3%
6/53 • Number of events 6
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Vascular disorders
Peripheral ischemia
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Vascular disorders
Thrombosis
|
4.0%
2/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
5.7%
3/53 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
Other adverse events
| Measure |
Std Tx + Pemetrexed
n=50 participants at risk
Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
|
Std Tx + Pemetrexed and Cetuximab
n=53 participants at risk
Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
4.0%
2/50 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
66.0%
33/50 • Number of events 119
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
54.7%
29/53 • Number of events 151
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Cardiac disorders
Left ventricular failure
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Cardiac disorders
Sinus tachycardia
|
2.0%
1/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
7.5%
4/53 • Number of events 5
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Eye disorders
Diplopia
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Eye disorders
Eye disorder
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Eye disorders
Vision blurred
|
6.0%
3/50 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
5.7%
3/53 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Eye disorders
Watering eyes
|
4.0%
2/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Abdominal pain
|
6.0%
3/50 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Constipation
|
40.0%
20/50 • Number of events 50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
26.4%
14/53 • Number of events 55
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Diarrhea
|
24.0%
12/50 • Number of events 17
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
24.5%
13/53 • Number of events 31
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Dry mouth
|
4.0%
2/50 • Number of events 10
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
5/50 • Number of events 11
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
15.1%
8/53 • Number of events 16
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Dysphagia
|
56.0%
28/50 • Number of events 92
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
64.2%
34/53 • Number of events 113
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
17.0%
9/53 • Number of events 20
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Esophageal mucositis
|
2.0%
1/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Esophageal pain
|
8.0%
4/50 • Number of events 9
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 16
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Esophageal stenosis
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
5.7%
3/53 • Number of events 7
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Esophagitis
|
44.0%
22/50 • Number of events 73
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
39.6%
21/53 • Number of events 44
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Flatulence
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Gastritis
|
4.0%
2/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
2.0%
1/50 • Number of events 8
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Mucositis oral
|
12.0%
6/50 • Number of events 9
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
18.9%
10/53 • Number of events 14
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Nausea
|
54.0%
27/50 • Number of events 73
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
45.3%
24/53 • Number of events 67
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Oesophagoscopy abnormal
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Oral pain
|
6.0%
3/50 • Number of events 6
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Salivary gland disorder
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
20/50 • Number of events 52
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
41.5%
22/53 • Number of events 44
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
General disorders
Chest pain
|
6.0%
3/50 • Number of events 6
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
5.7%
3/53 • Number of events 8
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
General disorders
Chills
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
General disorders
Edema limbs
|
2.0%
1/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 5
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
General disorders
Fatigue
|
86.0%
43/50 • Number of events 248
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
75.5%
40/53 • Number of events 230
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
General disorders
Fever
|
12.0%
6/50 • Number of events 6
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
7.5%
4/53 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
General disorders
Flu-like symptoms
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
General disorders
Gait abnormal
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
General disorders
General symptom
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
General disorders
Localized edema
|
4.0%
2/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
General disorders
Pain
|
4.0%
2/50 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
5.7%
3/53 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
General disorders
Sudden death
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Hepatobiliary disorders
Portal hypertension
|
2.0%
1/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Immune system disorders
Hypersensitivity
|
2.0%
1/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
5.7%
3/53 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Infections and infestations
Bladder infection
|
2.0%
1/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Infections and infestations
Bronchitis
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 5
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Infections and infestations
Eye infection
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Infections and infestations
Infection
|
14.0%
7/50 • Number of events 8
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Infections and infestations
Lip infection
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 6
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Infections and infestations
Lymph gland infection
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Infections and infestations
Opportunistic infection
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Infections and infestations
Otitis externa
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Infections and infestations
Peripheral nerve infection
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Infections and infestations
Pharyngitis
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Infections and infestations
Pneumonia
|
6.0%
3/50 • Number of events 5
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
7.5%
4/53 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Infections and infestations
Skin infection
|
4.0%
2/50 • Number of events 5
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Infections and infestations
Upper respiratory infection
|
6.0%
3/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Infections and infestations
Urinary tract infection
|
4.0%
2/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Infections and infestations
Vaginal infection
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
6.0%
3/50 • Number of events 5
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
5.7%
3/53 • Number of events 9
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
8.0%
4/50 • Number of events 11
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
4.0%
2/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Alanine aminotransferase increased
|
22.0%
11/50 • Number of events 20
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
26.4%
14/53 • Number of events 30
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Alkaline phosphatase increased
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
13.2%
7/53 • Number of events 17
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Aspartate aminotransferase increased
|
16.0%
8/50 • Number of events 15
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
18.9%
10/53 • Number of events 21
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Blood bilirubin increased
|
6.0%
3/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
7.5%
4/53 • Number of events 8
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Creatinine increased
|
12.0%
6/50 • Number of events 11
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
11.3%
6/53 • Number of events 11
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
INR increased
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
7.5%
4/53 • Number of events 5
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Laboratory test abnormal
|
4.0%
2/50 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Leukocyte count decreased
|
76.0%
38/50 • Number of events 141
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
84.9%
45/53 • Number of events 132
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Lymphocyte count decreased
|
20.0%
10/50 • Number of events 43
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
26.4%
14/53 • Number of events 70
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Neutrophil count decreased
|
56.0%
28/50 • Number of events 94
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
69.8%
37/53 • Number of events 97
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Platelet count decreased
|
64.0%
32/50 • Number of events 82
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
69.8%
37/53 • Number of events 111
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Weight gain
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Investigations
Weight loss
|
20.0%
10/50 • Number of events 30
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
18.9%
10/53 • Number of events 43
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Anorexia
|
34.0%
17/50 • Number of events 41
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
43.4%
23/53 • Number of events 130
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
36.0%
18/50 • Number of events 48
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
39.6%
21/53 • Number of events 52
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Dehydration
|
18.0%
9/50 • Number of events 10
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
26.4%
14/53 • Number of events 15
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
28.0%
14/50 • Number of events 30
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
37.7%
20/53 • Number of events 55
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
10.0%
5/50 • Number of events 7
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
17.0%
9/53 • Number of events 13
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
6.0%
3/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
6.0%
3/50 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
20.0%
10/50 • Number of events 13
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
20.8%
11/53 • Number of events 17
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
4.0%
2/50 • Number of events 6
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
22.0%
11/50 • Number of events 13
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
20.8%
11/53 • Number of events 19
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
5.7%
3/53 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
20.0%
10/50 • Number of events 16
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
18.9%
10/53 • Number of events 21
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.0%
2/50 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
9.4%
5/53 • Number of events 10
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
5/50 • Number of events 7
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
5.7%
3/53 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.0%
2/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
12.0%
6/50 • Number of events 17
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
2.0%
1/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.0%
4/50 • Number of events 10
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Musculoskeletal and connective tissue disorders
Upper extremity dysfunction
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Nervous system disorders
Ataxia
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Nervous system disorders
Dizziness
|
18.0%
9/50 • Number of events 22
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
13.2%
7/53 • Number of events 15
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Nervous system disorders
Dysgeusia
|
14.0%
7/50 • Number of events 15
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
11.3%
6/53 • Number of events 22
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Nervous system disorders
Facial nerve disorder
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Nervous system disorders
Headache
|
12.0%
6/50 • Number of events 8
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
11.3%
6/53 • Number of events 8
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
5.7%
3/53 • Number of events 5
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.0%
7/50 • Number of events 22
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
17.0%
9/53 • Number of events 28
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Nervous system disorders
Recurrent laryngeal nerve palsy
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 22
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Nervous system disorders
Syncope
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
7.5%
4/53 • Number of events 6
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Nervous system disorders
Tremor
|
2.0%
1/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Psychiatric disorders
Agitation
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Psychiatric disorders
Anxiety
|
6.0%
3/50 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
5.7%
3/53 • Number of events 14
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Psychiatric disorders
Confusion
|
4.0%
2/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Psychiatric disorders
Depression
|
6.0%
3/50 • Number of events 8
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
7.5%
4/53 • Number of events 15
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Psychiatric disorders
Insomnia
|
16.0%
8/50 • Number of events 30
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
17.0%
9/53 • Number of events 28
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Psychiatric disorders
Libido decreased
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Renal and urinary disorders
Hemoglobin urine positive
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Renal and urinary disorders
Urinary frequency
|
6.0%
3/50 • Number of events 7
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Renal and urinary disorders
Urinary incontinence
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Renal and urinary disorders
Urogenital disorder
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Reproductive system and breast disorders
Irregular menstruation
|
2.0%
1/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.0%
3/50 • Number of events 6
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
5.7%
3/53 • Number of events 10
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 11
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
4.0%
2/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
46.0%
23/50 • Number of events 61
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
41.5%
22/53 • Number of events 71
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
25/50 • Number of events 88
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
35.8%
19/53 • Number of events 51
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.0%
3/50 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.0%
2/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
9.4%
5/53 • Number of events 5
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.0%
2/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
5.7%
3/53 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.0%
1/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
2.0%
1/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.0%
3/50 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
14.0%
7/50 • Number of events 8
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
18.9%
10/53 • Number of events 18
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
4.0%
2/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
5.7%
3/53 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Tracheoscopy abnormal
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
4.0%
2/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
11.3%
6/53 • Number of events 31
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.0%
6/50 • Number of events 47
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
11.3%
6/53 • Number of events 35
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.0%
3/50 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 6
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.0%
2/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
9.4%
5/53 • Number of events 9
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.0%
3/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
56.6%
30/53 • Number of events 107
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
28.0%
14/50 • Number of events 21
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
37.7%
20/53 • Number of events 38
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Skin and subcutaneous tissue disorders
Sweating
|
4.0%
2/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Vascular disorders
Hot flashes
|
2.0%
1/50 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Vascular disorders
Hypertension
|
0.00%
0/50
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
3.8%
2/53 • Number of events 2
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Vascular disorders
Hypotension
|
8.0%
4/50 • Number of events 10
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
7.5%
4/53 • Number of events 4
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Vascular disorders
Lymphedema
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Vascular disorders
Peripheral ischemia
|
2.0%
1/50 • Number of events 10
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Vascular disorders
Phlebitis
|
4.0%
2/50 • Number of events 3
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
0.00%
0/53
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
|
Vascular disorders
Thrombosis
|
2.0%
1/50 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
1.9%
1/53 • Number of events 1
Adverse events were evaluated for 103 participants (50 and 53 on arm A and B, respectively).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place