Trial Outcomes & Findings for Study of Combretastatin and Paclitaxel/Carboplatin in the Treatment of Anaplastic Thyroid Cancer (NCT NCT00507429)
NCT ID: NCT00507429
Last Updated: 2014-06-09
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
80 participants
Primary outcome timeframe
From randomization to date last known alive
Results posted on
2014-06-09
Participant Flow
Study truncated from 180 to 80 subjects. Subjects were enrolled from August 2007 through March 2010 at 40 worldwide, academic and local-regional clinical sites.
During screening, the diagnosis of anaplastic thyroid cancer was centrally confirmed often leading to enrollment and randomization delays.
Participant milestones
| Measure |
Arm 1, Active: CA4P + Carboplatin + Paclitaxel
Randomized 2:1 to receive six 21-day cycles of CA4P (60mg/m2)on days 1, 8, 15 + carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2. Subjects without progressive disease may continue maintenance CA4P infusions until progressive disease, then followed monthly for survival.
|
Arm 2, Control: Carboplatin + Paclitaxel
On Day 2 of six 21-cycles subjects received Carboplatin (AUC 6) + paclitaxel (200 mg/m2). Subjects without progressive disease were followed monthly for survival.
|
|---|---|---|
|
Treatment Phase
STARTED
|
55
|
25
|
|
Treatment Phase
COMPLETED
|
18
|
7
|
|
Treatment Phase
NOT COMPLETED
|
37
|
18
|
|
Maintenance Phase
STARTED
|
16
|
0
|
|
Maintenance Phase
COMPLETED
|
2
|
0
|
|
Maintenance Phase
NOT COMPLETED
|
14
|
0
|
Reasons for withdrawal
| Measure |
Arm 1, Active: CA4P + Carboplatin + Paclitaxel
Randomized 2:1 to receive six 21-day cycles of CA4P (60mg/m2)on days 1, 8, 15 + carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2. Subjects without progressive disease may continue maintenance CA4P infusions until progressive disease, then followed monthly for survival.
|
Arm 2, Control: Carboplatin + Paclitaxel
On Day 2 of six 21-cycles subjects received Carboplatin (AUC 6) + paclitaxel (200 mg/m2). Subjects without progressive disease were followed monthly for survival.
|
|---|---|---|
|
Treatment Phase
Disease Progression
|
12
|
5
|
|
Treatment Phase
Adverse Event
|
12
|
5
|
|
Treatment Phase
Withdrawal by Subject
|
3
|
3
|
|
Treatment Phase
Physician Decision
|
4
|
2
|
|
Treatment Phase
Other
|
6
|
3
|
|
Maintenance Phase
Progressive Disease
|
14
|
0
|
Baseline Characteristics
Study of Combretastatin and Paclitaxel/Carboplatin in the Treatment of Anaplastic Thyroid Cancer
Baseline characteristics by cohort
| Measure |
Arm 1, Active: CA4P + Carboplatin + Paclitaxel
n=55 Participants
Randomized 2:1 to receive six 21-day cycles of CA4P (60mg/m2)on days 1, 8, 15 + carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2. Subjects without progressive disease may continue maintenance CA4P infusions until progressive disease, then followed monthly for survival.
|
Arm 2, Control: Carboplatin + Paclitaxel
n=25 Participants
On Day 2 of six 21-cycles subjects received Carboplatin (AUC 6) + paclitaxel (200 mg/m2). Subjects without progressive disease were followed monthly for survival.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 10.72 • n=99 Participants
|
61.2 years
STANDARD_DEVIATION 10.54 • n=107 Participants
|
61.4 years
STANDARD_DEVIATION 10.60 • n=206 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Region of Enrollment
Belarus
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
5 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
5 participants
n=99 Participants
|
1 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Region of Enrollment
Ukraine
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
Romania
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
Russian Federation
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
Bulgaria
|
3 participants
n=99 Participants
|
0 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
13 participants
n=99 Participants
|
8 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
India
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From randomization to date last known alivePopulation: All randomized subjects (the Intent-to-treat population) included in the analysis
Outcome measures
| Measure |
Arm 1, Active: CA4P + Carboplatin + Paclitaxel
n=55 Participants
Six 21-day cycles of CA4P (60 mg/m2) on days 1, 8, 15, carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 2
|
Arm 2, Comparator: Carboplatin + Paclitaxel
n=25 Participants
Six 21-day cycles of carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 1
|
|---|---|---|
|
Overall Survival
|
5.2 months
Interval 3.1 to 9.0
|
4.0 months
Interval 2.8 to 6.2
|
SECONDARY outcome
Timeframe: from randomization through end of study visitOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from randomization through end of study visitPopulation: Intent to treat
Outcome measures
| Measure |
Arm 1, Active: CA4P + Carboplatin + Paclitaxel
n=55 Participants
Six 21-day cycles of CA4P (60 mg/m2) on days 1, 8, 15, carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 2
|
Arm 2, Comparator: Carboplatin + Paclitaxel
n=25 Participants
Six 21-day cycles of carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 1
|
|---|---|---|
|
To Determine Percentage of 1 Year Survival
|
26 percentage of participants
|
9 percentage of participants
|
Adverse Events
Arm 1, Active: CA4P + Carboplatin + Paclitaxel
Serious events: 21 serious events
Other events: 50 other events
Deaths: 0 deaths
Arm 2, Comparator: Carboplatin + Paclitaxel
Serious events: 5 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1, Active: CA4P + Carboplatin + Paclitaxel
n=51 participants at risk
Six 21-day cycles of CA4P (60 mg/m2) on days 1, 8, 15, carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 2
|
Arm 2, Comparator: Carboplatin + Paclitaxel
n=24 participants at risk
Six 21-day cycles of carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 1
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
8.3%
2/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Infections and infestations
Bronchitis
|
9.8%
5/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
8.3%
2/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Infections and infestations
Cellulitis
|
3.9%
2/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Gastrointestinal disorders
Diarrhea
|
3.9%
2/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.8%
4/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
General disorders
Edema peripheral
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Gastrointestinal disorders
Esophageal fistual
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Gastrointestinal disorders
Esophageal obstruction
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
5.9%
3/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Nervous system disorders
Hemiparesis
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Nervous system disorders
Hypoxic encephalopathy
|
0.00%
0/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Gastrointestinal disorders
Intestinal hemorrhage
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
General disorders
Necrosis
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.9%
2/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive Airways Disorders
|
3.9%
2/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Infections and infestations
Osteomyelitis
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
General disorders
Performance status decreased
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.9%
2/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Reproductive system and breast disorders
Pulmonay embolism
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
General disorders
Pyrexia
|
3.9%
2/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.9%
2/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Cardiac disorders
Sinus bradycardia
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Infections and infestations
Tooth infection
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Blood and lymphatic system disorders
Tumor hemorrhage
|
3.9%
2/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
General disorders
Tumor pain
|
3.9%
2/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
Other adverse events
| Measure |
Arm 1, Active: CA4P + Carboplatin + Paclitaxel
n=51 participants at risk
Six 21-day cycles of CA4P (60 mg/m2) on days 1, 8, 15, carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 2
|
Arm 2, Comparator: Carboplatin + Paclitaxel
n=24 participants at risk
Six 21-day cycles of carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 1
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
11.8%
6/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
8.3%
2/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.8%
4/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Investigations
Alanine transferase increased
|
7.8%
4/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
31.4%
16/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
12.5%
3/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Blood and lymphatic system disorders
Anemia
|
39.2%
20/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
50.0%
12/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Metabolism and nutrition disorders
Anorexia
|
17.6%
9/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
8.3%
2/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.6%
9/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
8.3%
2/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
3/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
General disorders
Asthenia
|
3.9%
2/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
8.3%
2/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
19.6%
10/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
7.8%
4/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.9%
3/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
8.3%
2/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Metabolism and nutrition disorders
Cachexia
|
7.8%
4/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Infections and infestations
Cellulitis
|
5.9%
3/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
General disorders
Chills
|
5.9%
3/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Gastrointestinal disorders
Constipation
|
23.5%
12/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.8%
6/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
8.3%
2/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.8%
4/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Gastrointestinal disorders
Diarrhea
|
29.4%
15/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
16.7%
4/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
General disorders
Disease Progression
|
13.7%
7/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Nervous system disorders
Dizziness
|
7.8%
4/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Gastrointestinal disorders
Dry mouth
|
5.9%
3/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Nervous system disorders
Dysgeusia
|
7.8%
4/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspea
|
29.4%
15/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
16.7%
4/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Gastrointestinal disorders
Dysphagia
|
29.4%
15/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
7.8%
4/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Investigations
Electrocardiogram QT prolonged
|
15.7%
8/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.8%
5/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
General disorders
Fatigue
|
35.3%
18/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
29.2%
7/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.9%
3/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
8.3%
2/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Vascular disorders
Flushing
|
11.8%
6/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Nervous system disorders
Headache
|
27.5%
14/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
8.3%
2/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
21.6%
11/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.8%
4/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
7.8%
4/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Musculoskeletal and connective tissue disorders
Hyperglycemia
|
7.8%
4/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
11.8%
6/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Vascular disorders
Hypertension
|
35.3%
18/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.8%
5/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
13.7%
7/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.9%
3/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
17.6%
9/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
13.7%
7/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.8%
4/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Vascular disorders
Hypotension
|
11.8%
6/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.9%
3/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Psychiatric disorders
Insomnia
|
5.9%
3/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Blood and lymphatic system disorders
Leukopenia
|
41.2%
21/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
8.3%
2/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.8%
5/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.9%
3/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.8%
4/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.8%
6/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
8.3%
2/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Gastrointestinal disorders
Nausea
|
29.4%
15/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
20.8%
5/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
21.6%
11/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
12.5%
3/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.9%
3/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Blood and lymphatic system disorders
Neutropenia
|
58.8%
30/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
29.2%
7/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
General disorders
Non-cardiac chest pain
|
7.8%
4/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airway disorder
|
5.9%
3/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
General disorders
Oedema peripheral
|
9.8%
5/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.7%
7/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
8.3%
2/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Nervous system disorders
Paraesthesia
|
11.8%
6/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
12.5%
3/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
15.7%
8/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
11.8%
6/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.9%
3/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
General disorders
Pyrexia
|
27.5%
14/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
16.7%
4/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
11.8%
6/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
8.3%
2/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.9%
3/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Cardiac disorders
Sinus tachycardia
|
15.7%
8/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
8.3%
2/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Cardiac disorders
Tachycardia
|
7.8%
4/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
19.6%
10/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
8.3%
2/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Respiratory, thoracic and mediastinal disorders
Tremor
|
5.9%
3/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Infections and infestations
Upper respiratory infection
|
5.9%
3/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Infections and infestations
Urinary tract infection
|
7.8%
4/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
4.2%
1/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Gastrointestinal disorders
Vomiting
|
25.5%
13/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
29.2%
7/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
|
Investigations
Weight decreased
|
11.8%
6/51 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
0.00%
0/24 • Adverse event data was collected over 2 years, 6 months. All serious adverse events were reported, regardless of relatedness. Adverse events occurring at a frequency of >/= 5% in either arm are reported, regardless of relatedness.
The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place