Trial Outcomes & Findings for Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer (NCT NCT00704730)
NCT ID: NCT00704730
Last Updated: 2021-04-20
Results Overview
The duration of Progression-Free Survival (PFS) using progression events as determined by Independent Review Committee (IRC) per mRECIST, or death due to any cause. The analysis was conducted after at least 315 subjects were randomized and at least 138 events were observed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
330 participants
Primary outcome timeframe
Treatment period consisted of 4-week cycles with radiologic tumor assessment every 12 weeks from date of randomization until date of first documented PD or date of death from any cause, whichever came first, assessed up to 34 months.
Results posted on
2021-04-20
Participant Flow
First patient enrolled 10 September 2008, last patient enrolled 27 February 2011. Data cut off date 15 June 2011.
Participant milestones
| Measure |
XL184 (Cabozantinib)
XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
|
Placebo
oral capsules once daily
|
|---|---|---|
|
Overall Study
STARTED
|
219
|
111
|
|
Overall Study
COMPLETED
|
98
|
15
|
|
Overall Study
NOT COMPLETED
|
121
|
96
|
Reasons for withdrawal
| Measure |
XL184 (Cabozantinib)
XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
|
Placebo
oral capsules once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
35
|
9
|
|
Overall Study
Death
|
11
|
5
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Did not receive drug
|
5
|
2
|
|
Overall Study
Disease progression per PI
|
58
|
67
|
|
Overall Study
data unavailable
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
9
|
13
|
Baseline Characteristics
Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer
Baseline characteristics by cohort
| Measure |
XL184 (Cabozantinib)
n=219 Participants
XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
|
Placebo
n=111 Participants
oral capsules once daily
|
Total
n=330 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
|
172 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
258 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
47 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 13.33 • n=99 Participants
|
53.8 years
STANDARD_DEVIATION 13.39 • n=107 Participants
|
54.2 years
STANDARD_DEVIATION 13.33 • n=206 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
151 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
221 Participants
n=206 Participants
|
|
Region of Enrollment
Austria
|
8 participants
n=99 Participants
|
1 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
7 participants
n=99 Participants
|
5 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
4 participants
n=99 Participants
|
3 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
6 participants
n=99 Participants
|
2 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Region of Enrollment
Chile
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
Denmark
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
France
|
25 participants
n=99 Participants
|
5 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
15 participants
n=99 Participants
|
10 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
Region of Enrollment
Greece
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
Portugal
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
India
|
5 participants
n=99 Participants
|
1 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
28 participants
n=99 Participants
|
14 participants
n=107 Participants
|
42 participants
n=206 Participants
|
|
Region of Enrollment
Korea, Republic of
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
5 participants
n=99 Participants
|
3 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Region of Enrollment
Peru
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
12 participants
n=99 Participants
|
3 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Region of Enrollment
Russian Federation
|
8 participants
n=99 Participants
|
5 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
5 participants
n=99 Participants
|
3 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Region of Enrollment
Switzerland
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
Sweden
|
6 participants
n=99 Participants
|
4 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=99 Participants
|
9 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=99 Participants
|
31 participants
n=107 Participants
|
94 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Treatment period consisted of 4-week cycles with radiologic tumor assessment every 12 weeks from date of randomization until date of first documented PD or date of death from any cause, whichever came first, assessed up to 34 months.Population: Intent to Treat (ITT) 330 subjects were randomized and were included in the analysis. A Kaplan-Meyer analysis was performed to estimate the median.
The duration of Progression-Free Survival (PFS) using progression events as determined by Independent Review Committee (IRC) per mRECIST, or death due to any cause. The analysis was conducted after at least 315 subjects were randomized and at least 138 events were observed.
Outcome measures
| Measure |
XL184 (Cabozantinib)
n=219 Participants
XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily.
|
Placebo
n=111 Participants
Oral capsules once daily
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
11.2 months
Interval 9.3 to 13.7
|
4.0 months
Interval 3.0 to 5.4
|
SECONDARY outcome
Timeframe: The pre-specified interim analysis of Overall Survival (OS) was assessed at 44% of required events. Includes data up to 15June2011. As of this date, the number of deaths required to conduct the primary analysis had not been reached.Population: Intent to treat (ITT) randomized to either XL184 or placebo
Duration of Overall Survival (OS) from the time of randomization to death due to any cause. A Kaplan-Meier analysis was performed to estimate the median.
Outcome measures
| Measure |
XL184 (Cabozantinib)
n=219 Participants
XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily.
|
Placebo
n=111 Participants
Oral capsules once daily
|
|---|---|---|
|
Overall Survival (OS) With XL184 Compared With Placebo
|
21.1 months
Interval 16.59 to 28.52
|
NA months
Interval 17.41 to
Median duration OS could not be estimated for placebo at data cut-off June 15, 2011 due to insufficient number of participants with events. At time of analysis of PFS, number of deaths required to conduct primary analysis of OS was not reached.
|
SECONDARY outcome
Timeframe: Assessed at the same time as primary analysis of Progression Free Survival (PFS) data. Assessed at baseline and every 12 weeks until Progressive Disease (PD) up to 34 months.Population: The primary analysis Objective Response Rate (ORR) was performed among subset of Intent To Treat (ITT) subjects with measurable disease at baseline (N = 208 cabozantinib, N = 104 placebo) based upon response determined by Independent Radiology Committee (IRC.) Subjects without post-baseline adequate tumor assessments - counted as nonresponders.
The proportion of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as determined by the Independent Review Committee (IRC.) Per Response Evaluation Criteria in Solid Tumor Criteria (mRECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) ≥ 20% increase in the sum of the longest diameter of target lesions. Overall Response Rate: ORR=CR +PR
Outcome measures
| Measure |
XL184 (Cabozantinib)
n=208 Participants
XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily.
|
Placebo
n=104 Participants
Oral capsules once daily
|
|---|---|---|
|
Objective Response Rate (ORR)
|
28 % of participants
Interval 21.9 to 34.5
|
0 % of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: From time of first documentation of Objective Response (OR), confirmed at a later visit ≥28 days later as Progressive Disease (PD) as defined by mRECIST or death due to any cause, assessed up to 34 months.Population: The primary analysis of Objective Response Rate (ORR) was performed among the subset of Intent To Treat (ITT) subjects with measurable disease at baseline and was based upon response as determined by the Independent Review Committee (IRC.) Subjects who did not have post-baseline adequate tumor assessments were counted as nonresponders.
For those subjects with Independent Radiology Committee (IRC) determined Objective Response Rate (ORR), the amount of time from documentation of Objective Response (OR) until Progressive Disease (PD) by mRECIST or death due to any cause.
Outcome measures
| Measure |
XL184 (Cabozantinib)
n=58 Participants
XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily.
|
Placebo
Oral capsules once daily
|
|---|---|---|
|
Duration of Objective Response (OR): Independent Radiology Committee (IRC) Determined
|
14.6 months
Interval 11.1 to 17.5
|
—
|
SECONDARY outcome
Timeframe: Serum tumor markers CTN evaluated from blood samples collected at screening and every 12 weeks (±5 days from randomization) until date of first documented progression or date of death from any cause, whichever came first, assessed for up to 34 months.Population: Population was intent to treat (ITT), randomized to either XL184 or placebo. For the CTN measure the analysis population differs from the ITT population of 219 XL184 and 111 Placebo. Three subjects did not provide samples for CTN. The biomarker analysis was based on available samples, not on ITT.
For each on-treatment tumor marker assessment from each subject, the biochemical response of CTN was determined based on percent increase or decrease from baseline. Best biochemical response over course of treatment was determined from evaluation of subject's time point response data. Biochemical response criteria: Complete Response (CR) - decrease in tumor marker into normal range from baseline value; Partial Response (PR) - decrease of \>50% from baseline value when baseline value is above normal range; Stable Disease (SD) - no more than a 50% increase and no more than a 50% decrease from baseline value above normal range; Progressive Disease (PD) - increase of \>50% from baseline value when baseline value is above normal range / or increase from low or normal range at baseline to above normal range; Not Evaluable (NE) - missing baseline value / or baseline value is not elevated and response is not PD / or response can not be determined due to change in assay format.
Outcome measures
| Measure |
XL184 (Cabozantinib)
n=217 Participants
XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily.
|
Placebo
n=110 Participants
Oral capsules once daily
|
|---|---|---|
|
Biochemical Response Calcitonin (CTN) %
|
22.6 % participants
60.71
|
0.9 % participants
115.4
|
SECONDARY outcome
Timeframe: Serum tumor markers CEA evaluated from blood samples collected at screening and every 12 weeks (± 5 days from randomization) until date of first documented progression or date of death from any cause, whichever came first, assessed for up to 34 months.Population: For the CEA measure the analysis population differs from the Intent To Treat (ITT) population of 219 XL184 and 111 Placebo. One subject did not provide samples for CEA. The biomarker analysis was based on available samples, not on ITT.
For each on-treatment tumor marker assessment from each subject, the biochemical response of CEA was determined based on percent increase or decrease from baseline. Best biochemical response over the course of treatment was determined from evaluation of each subject's time point response data. Biochemical response: Complete Response (CR)- Decrease in tumor marker into normal range from baseline value; Partial Response (PR)- Decrease of \>50% from baseline value when baseline value is above normal range; Stable Disease (SD)- No more than a 50% increase and no more than a 50% decrease from baseline value above normal range; Progressive Disease (PD)- Increase of \>50% from baseline value when baseline value is above normal range / or increase from low or normal range at baseline to above normal range; Not Evaluable (NE)- Missing baseline value / or baseline value is not elevated and response is not Progressive Disease (PD) / or response can not be determined due to change in assay format.
Outcome measures
| Measure |
XL184 (Cabozantinib)
n=218 Participants
XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily.
|
Placebo
n=111 Participants
Oral capsules once daily
|
|---|---|---|
|
Biochemical Response Carcinoembryonic Antigen (CEA) %
|
21.6 % of participants
58.21
|
0.9 % of participants
182.6
|
Adverse Events
XL184 (Cabozantinib)
Serious events: 90 serious events
Other events: 213 other events
Deaths: 0 deaths
Placebo
Serious events: 25 serious events
Other events: 102 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
XL184 (Cabozantinib)
n=214 participants at risk
XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
|
Placebo
n=109 participants at risk
oral capsules once daily
|
|---|---|---|
|
General disorders
Mucosal inflammation
|
2.8%
6/214 • Number of events 6 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
General disorders
Multi-organ failure
|
1.4%
3/214 • Number of events 3 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.4%
3/214 • Number of events 3 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Cardiac disorders
Atrial fibrillation
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/214 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Cardiac disorders
Cardiac arrest
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Endocrine disorders
Ectopic acth syndrome
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
3/214 • Number of events 3 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Anal fissure
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Anal fistula
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Ascites
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
3/214 • Number of events 3 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Dysphagia
|
2.3%
5/214 • Number of events 5 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
1.8%
2/109 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Glossodynia
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.93%
2/214 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.93%
2/214 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Nausea
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Oesophageal fistula
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.4%
3/214 • Number of events 3 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/214 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Peritonitis
|
0.93%
2/214 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Pneumoperitonem
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/214 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
4/214 • Number of events 4 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
General disorders
Asthenia
|
0.93%
2/214 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
1.8%
2/109 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
General disorders
Chest pain
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
General disorders
Death
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
General disorders
Fatigue
|
1.9%
4/214 • Number of events 4 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
General disorders
General physical health deterioration
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
1.8%
2/109 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
General disorders
Injection site haematoma
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
General disorders
Non-cardiac chest pain
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
General disorders
Oedema peripheral
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
General disorders
Performance status decreased
|
0.93%
2/214 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
General disorders
Pyrexia
|
0.93%
2/214 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
General disorders
Sudden death
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Immune system disorders
Hypersensitivity
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Anal abscess
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Appendicitis perforated
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Aspergilloma
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Bronchitis
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Bronchopneumonia
|
0.93%
2/214 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Clostridial infection
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Device related infection
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Fungal oesophagitis
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Gastrointestinal infection
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Infectious mononucleosis
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/214 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Septic shock
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Lung abscess
|
1.4%
3/214 • Number of events 3 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Peridiverticular abscess
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Pneumonia
|
3.3%
7/214 • Number of events 7 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
2.8%
3/109 • Number of events 3 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Pneumonia bacterial
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Salmonellosis
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Sepsis
|
1.4%
3/214 • Number of events 3 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Tracheitis
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/214 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Urinary tract infection
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Wound infection
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/214 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Injury, poisoning and procedural complications
Tracheal haemorrhage
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Investigations
Blood amylase increased
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Investigations
C-reactive protein increased
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Investigations
Electrocardiogram ST segment depression
|
0.00%
0/214 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Investigations
Eosinophil count increased
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Investigations
Haemoglobin decreased
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Investigations
Lipase increased
|
1.4%
3/214 • Number of events 3 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Investigations
Liver function test abnormal
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Investigations
Transaminases increased
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.93%
2/214 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
5/214 • Number of events 5 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.8%
6/214 • Number of events 6 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.4%
3/214 • Number of events 3 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/214 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/214 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/214 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to oesophagus
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to trachea
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/214 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Nervous system disorders
Cerebral infarction
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Nervous system disorders
Convulsion
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.93%
2/214 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Nervous system disorders
Loss of consciousness
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Nervous system disorders
Syncope
|
0.93%
2/214 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Psychiatric disorders
Agitation
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/214 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Psychiatric disorders
Delirium
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Psychiatric disorders
Suicide attempt
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Renal and urinary disorders
Proteinuria
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Renal and urinary disorders
Renal failure
|
0.93%
2/214 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Acquired tracheo-oesophageal fistula
|
1.4%
3/214 • Number of events 3 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/214 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.93%
2/214 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
5.5%
6/109 • Number of events 6 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.93%
2/214 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.93%
2/214 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum perforation
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/214 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.9%
4/214 • Number of events 4 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.3%
5/214 • Number of events 5 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary necrosis
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal fistula
|
0.93%
2/214 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
1.4%
3/214 • Number of events 3 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Vascular disorders
Arterial thrombosis limb
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Vascular disorders
Deep vein thrombosis
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Vascular disorders
Haemorrhage
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Vascular disorders
Hypertension
|
2.3%
5/214 • Number of events 5 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Vascular disorders
Hypotension
|
1.4%
3/214 • Number of events 3 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Vascular disorders
Shock
|
0.00%
0/214 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/214 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.47%
1/214 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
Other adverse events
| Measure |
XL184 (Cabozantinib)
n=214 participants at risk
XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
|
Placebo
n=109 participants at risk
oral capsules once daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.5%
14/214 • Number of events 14 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
9.2%
10/109 • Number of events 10 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.1%
11/214 • Number of events 11 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
1.8%
2/109 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Endocrine disorders
Hypothyroidism
|
9.3%
20/214 • Number of events 20 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.9%
34/214 • Number of events 34 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
6.4%
7/109 • Number of events 7 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.5%
16/214 • Number of events 16 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
5.5%
6/109 • Number of events 6 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Constipation
|
26.6%
57/214 • Number of events 57 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
5.5%
6/109 • Number of events 6 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Diarrhoea
|
63.1%
135/214 • Number of events 135 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
33.0%
36/109 • Number of events 36 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Dry mouth
|
13.1%
28/214 • Number of events 28 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
8.3%
9/109 • Number of events 9 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.2%
24/214 • Number of events 24 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Dysphagia
|
11.7%
25/214 • Number of events 25 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
6.4%
7/109 • Number of events 7 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Flatulence
|
7.0%
15/214 • Number of events 15 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
3.7%
4/109 • Number of events 4 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Glossodynia
|
9.8%
21/214 • Number of events 21 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.9%
17/214 • Number of events 17 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
2.8%
3/109 • Number of events 3 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Nausea
|
43.0%
92/214 • Number of events 92 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
21.1%
23/109 • Number of events 23 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Oral pain
|
13.6%
29/214 • Number of events 29 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Stomatitis
|
29.0%
62/214 • Number of events 62 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
2.8%
3/109 • Number of events 3 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Gastrointestinal disorders
Vomiting
|
23.8%
51/214 • Number of events 51 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
1.8%
2/109 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
General disorders
Asthenia
|
20.1%
43/214 • Number of events 43 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
12.8%
14/109 • Number of events 14 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
General disorders
Fatigue
|
40.2%
86/214 • Number of events 86 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
28.4%
31/109 • Number of events 31 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
General disorders
Mucosal inflamation
|
21.5%
46/214 • Number of events 46 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
3.7%
4/109 • Number of events 4 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
General disorders
Oedema peripheral
|
9.3%
20/214 • Number of events 20 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
11.9%
13/109 • Number of events 13 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
General disorders
Pain
|
5.6%
12/214 • Number of events 12 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
3.7%
4/109 • Number of events 4 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
General disorders
Pyrexia
|
8.9%
19/214 • Number of events 19 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
6.4%
7/109 • Number of events 7 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Nasopharyngitis
|
4.7%
10/214 • Number of events 10 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
7.3%
8/109 • Number of events 8 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.9%
17/214 • Number of events 17 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
3.7%
4/109 • Number of events 4 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Infections and infestations
Urinary tract infection
|
7.5%
16/214 • Number of events 16 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
2.8%
3/109 • Number of events 3 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Investigations
Alanine aminotransferase increased
|
21.5%
46/214 • Number of events 46 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
5.5%
6/109 • Number of events 6 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Investigations
Aspartate aminotransferase increased
|
21.5%
46/214 • Number of events 46 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
5.5%
6/109 • Number of events 6 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.9%
17/214 • Number of events 17 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
2.8%
3/109 • Number of events 3 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Investigations
Blood amylase increased
|
6.5%
14/214 • Number of events 14 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
10.1%
11/109 • Number of events 11 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Investigations
Blood lactate dehydrogenase increased
|
18.2%
39/214 • Number of events 39 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
2.8%
3/109 • Number of events 3 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
13.1%
28/214 • Number of events 28 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
2.8%
3/109 • Number of events 3 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Investigations
Lipase increased
|
10.7%
23/214 • Number of events 23 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
11.9%
13/109 • Number of events 13 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Investigations
Weight decreased
|
47.7%
102/214 • Number of events 102 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
10.1%
11/109 • Number of events 11 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
45.8%
98/214 • Number of events 98 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
15.6%
17/109 • Number of events 17 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
12/214 • Number of events 12 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
20.1%
43/214 • Number of events 43 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
4.6%
5/109 • Number of events 5 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.3%
22/214 • Number of events 22 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
3.7%
4/109 • Number of events 4 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.1%
28/214 • Number of events 28 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
7.3%
8/109 • Number of events 8 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.0%
32/214 • Number of events 32 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
11.0%
12/109 • Number of events 12 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.1%
11/214 • Number of events 11 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
4.6%
5/109 • Number of events 5 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.93%
2/214 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
5.5%
6/109 • Number of events 6 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.1%
26/214 • Number of events 26 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
4.6%
5/109 • Number of events 5 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
8.9%
19/214 • Number of events 19 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
3.7%
4/109 • Number of events 4 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.6%
12/214 • Number of events 12 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
5.5%
6/109 • Number of events 6 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.1%
13/214 • Number of events 13 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
3.7%
4/109 • Number of events 4 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.0%
15/214 • Number of events 15 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
4.6%
5/109 • Number of events 5 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.4%
33/214 • Number of events 33 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
11.0%
12/109 • Number of events 12 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Nervous system disorders
Dizziness
|
13.6%
29/214 • Number of events 29 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
7.3%
8/109 • Number of events 8 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Nervous system disorders
Dysgeusia
|
34.1%
73/214 • Number of events 73 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
5.5%
6/109 • Number of events 6 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Nervous system disorders
Headache
|
18.2%
39/214 • Number of events 39 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
8.3%
9/109 • Number of events 9 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.1%
11/214 • Number of events 11 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Nervous system disorders
Paraesthesia
|
7.5%
16/214 • Number of events 16 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
1.8%
2/109 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.5%
14/214 • Number of events 14 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Psychiatric disorders
Anxiety
|
8.9%
19/214 • Number of events 19 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
1.8%
2/109 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Psychiatric disorders
Depression
|
6.5%
14/214 • Number of events 14 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
2.8%
3/109 • Number of events 3 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Psychiatric disorders
Insomnia
|
10.7%
23/214 • Number of events 23 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
6.4%
7/109 • Number of events 7 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.1%
26/214 • Number of events 26 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
12.8%
14/109 • Number of events 14 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
20.1%
43/214 • Number of events 43 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
9.2%
10/109 • Number of events 10 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.6%
27/214 • Number of events 27 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
16.5%
18/109 • Number of events 18 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.9%
19/214 • Number of events 19 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
11.0%
12/109 • Number of events 12 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
17.8%
38/214 • Number of events 38 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
4.6%
5/109 • Number of events 5 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.4%
35/214 • Number of events 35 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
1.8%
2/109 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
6.5%
14/214 • Number of events 14 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
1.8%
2/109 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
19.2%
41/214 • Number of events 41 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
2.8%
3/109 • Number of events 3 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.7%
23/214 • Number of events 23 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
1.8%
2/109 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
33.6%
72/214 • Number of events 72 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.92%
1/109 • Number of events 1 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.9%
4/214 • Number of events 4 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
5.5%
6/109 • Number of events 6 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
7.5%
16/214 • Number of events 16 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
49.1%
105/214 • Number of events 105 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
1.8%
2/109 • Number of events 2 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.1%
13/214 • Number of events 13 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
6.4%
7/109 • Number of events 7 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.2%
41/214 • Number of events 41 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
10.1%
11/109 • Number of events 11 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Vascular disorders
Hypertension
|
29.0%
62/214 • Number of events 62 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
3.7%
4/109 • Number of events 4 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
|
Vascular disorders
Hypotension
|
5.1%
11/214 • Number of events 11 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
0.00%
0/109 • From baseline at regular intervals through to the date of the primary analysis
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PIs may publish trial results generated at his/ her site with sponsor's prior written consent and only after results of the trial from all participating sites have been released in a multi-center publication coordinated by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER