Trial Outcomes & Findings for Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100 (NCT NCT01605227)
NCT ID: NCT01605227
Last Updated: 2018-03-14
Results Overview
The primary analysis of OS is defined as the time from randomization to death due to any cause. Participants that had not died or were permanently lost to follow-up were censored at the last known date alive. Median OS was calculated using Kaplan-Meier estimates. Analysis for OS was performed after 614 events had occurred.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1028 participants
Primary outcome timeframe
OS was measured from the time of randomization until 614 events, approximately 24 months after study start
Results posted on
2018-03-14
Participant Flow
First patient enrolled: 02 July 2012 (first subject randomized), Data cut off date: 07 July 2014
Participant milestones
| Measure |
Cabozantinib
Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.
Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily.
|
Prednisone
Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.
Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
682
|
346
|
|
Overall Study
COMPLETED
|
61
|
17
|
|
Overall Study
NOT COMPLETED
|
621
|
329
|
Reasons for withdrawal
| Measure |
Cabozantinib
Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.
Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily.
|
Prednisone
Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.
Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily.
|
|---|---|---|
|
Overall Study
Did not receive study treatment
|
2
|
3
|
|
Overall Study
Adverse Event
|
228
|
42
|
|
Overall Study
Progressive Disease
|
132
|
128
|
|
Overall Study
Clinical Deterioration
|
227
|
133
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Physician Decision
|
9
|
7
|
|
Overall Study
Withdrawal by Subject
|
18
|
14
|
|
Overall Study
Sponsor Decision
|
2
|
0
|
|
Overall Study
Started New Therapy
|
1
|
0
|
|
Overall Study
Subject Decision
|
0
|
1
|
|
Overall Study
Dose Held >6 weeks
|
0
|
1
|
Baseline Characteristics
Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100
Baseline characteristics by cohort
| Measure |
Cabozantinib
n=682 Participants
Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.
Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily.
|
Prednisone
n=346 Participants
Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.
Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily.
|
Total
n=1028 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
165 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
262 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
517 Participants
n=5 Participants
|
249 Participants
n=7 Participants
|
766 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
682 Participants
n=5 Participants
|
346 Participants
n=7 Participants
|
1028 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
520 Participants
n=5 Participants
|
265 Participants
n=7 Participants
|
785 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
146 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
|
Region of Enrollment
North America
|
119 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
528 Participants
n=5 Participants
|
256 Participants
n=7 Participants
|
784 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
35 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Prior cabazitaxel (per CRF)
Yes
|
261 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
393 Participants
n=5 Participants
|
|
Prior cabazitaxel (per CRF)
No
|
421 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
635 Participants
n=5 Participants
|
|
Brief Pain Inventory (BPI) Item 3 (per CRF)
<4
|
389 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
585 Participants
n=5 Participants
|
|
Brief Pain Inventory (BPI) Item 3 (per CRF)
≥4
|
284 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
432 Participants
n=5 Participants
|
|
Brief Pain Inventory (BPI) Item 3 (per CRF)
Missing
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
ECOG Performance Status (per CRF)
0/1 (asymptomatic or symptomatic but ambulatory)
|
605 participants
n=5 Participants
|
303 participants
n=7 Participants
|
908 participants
n=5 Participants
|
|
ECOG Performance Status (per CRF)
2 (ambulatory but can't carry out work activities)
|
76 participants
n=5 Participants
|
43 participants
n=7 Participants
|
119 participants
n=5 Participants
|
|
ECOG Performance Status (per CRF)
Missing
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Opioid narcotic use within 24 hours (per solicited oploid CRF)
|
454 Participants
n=5 Participants
|
228 Participants
n=7 Participants
|
682 Participants
n=5 Participants
|
|
Concomitant prednisone/prednisolone at randomization
|
289 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
431 Participants
n=5 Participants
|
|
Time from diagnosis to study entry
|
6.68 years
n=5 Participants
|
6.98 years
n=7 Participants
|
6.83 years
n=5 Participants
|
|
Bone scan lesion area
|
45,635.5 mm^2
n=5 Participants
|
41,746.0 mm^2
n=7 Participants
|
44,782.0 mm^2
n=5 Participants
|
|
Extent of metastasis
None
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Extent of metastasis
Bone
|
681 participants
n=5 Participants
|
346 participants
n=7 Participants
|
1027 participants
n=5 Participants
|
|
Extent of metastasis
Lymph node
|
313 participants
n=5 Participants
|
140 participants
n=7 Participants
|
453 participants
n=5 Participants
|
|
Extent of metastasis
Visceral
|
133 participants
n=5 Participants
|
58 participants
n=7 Participants
|
191 participants
n=5 Participants
|
|
Extent of metastasis
Liver
|
91 participants
n=5 Participants
|
35 participants
n=7 Participants
|
126 participants
n=5 Participants
|
|
Extent of metastasis
Lung
|
69 participants
n=5 Participants
|
29 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
Extent of metastasis
Other soft tissue
|
39 participants
n=5 Participants
|
23 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
No. of prior anticancer agents
2
|
57 participants
n=5 Participants
|
31 participants
n=7 Participants
|
88 participants
n=5 Participants
|
|
No. of prior anticancer agents
≥3
|
625 participants
n=5 Participants
|
315 participants
n=7 Participants
|
940 participants
n=5 Participants
|
|
Baseline LDH
|
230 U/L
n=5 Participants
|
230 U/L
n=7 Participants
|
230 U/L
n=5 Participants
|
|
Baseline PSA
|
192 μg/L
n=5 Participants
|
195 μg/L
n=7 Participants
|
192 μg/L
n=5 Participants
|
|
Baseline serum testosterone (<50 ng/dL)
|
677 Participants
n=5 Participants
|
345 Participants
n=7 Participants
|
1022 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: OS was measured from the time of randomization until 614 events, approximately 24 months after study startPopulation: The Intent to Treat (ITT) population was used and included 1028 randomized subjects (682 cabozantinib, 346 prednisone).
The primary analysis of OS is defined as the time from randomization to death due to any cause. Participants that had not died or were permanently lost to follow-up were censored at the last known date alive. Median OS was calculated using Kaplan-Meier estimates. Analysis for OS was performed after 614 events had occurred.
Outcome measures
| Measure |
Cabozantinib
n=682 Participants
Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.
Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily.
|
Prednisone
n=346 Participants
Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.
Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily.
|
|---|---|---|
|
Overall Survival (OS)
|
11.0 months
Interval 10.09 to 11.63
|
9.8 months
Interval 9.0 to 11.53
|
SECONDARY outcome
Timeframe: BSR was measured at the end of Week 12 as determined by the IRFPopulation: Analysis was conducted on the ITT population (682 cabozantinib, 346 prednisone) for Bone Scan Response (BSR) at Week 12.
BSR is defined as \>=30% reduction in the bone scan lesion area (BSLA) compared with baseline. Confirmation of bone scan was not required for response or progression. Bone scans were evaluated by an independent radiology facility (IRF) for response.
Outcome measures
| Measure |
Cabozantinib
n=682 Participants
Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.
Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily.
|
Prednisone
n=346 Participants
Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.
Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily.
|
|---|---|---|
|
Bone Scan Response (BSR)
|
42 percentage of participants
Interval 38.0 to 46.0
|
3 percentage of participants
Interval 1.0 to 5.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Duration of PFS was defined as time from the date of randomization to earlier of date of radiographic progression (bone/andor soft tissue) according to the investigator's assessment or death, assessed for up to approximately 24 monthsPopulation: The Intent to Treat (ITT) population was used and include 1028 randomized subjects (682 cabozantinib, 346 prednisone) with a data cut off date of 07 July 2014.
The exploratory analysis of PFS is the time from randomization to date of first documented radiographic progression (bone and/or soft tissue) according to the investigator's assessment or death. PFS was defined per mRECIST 1.1 and included evaluation of measurable, nonmeasurable, target and nontarget lesions. A Kaplan-Meier analysis was performed to estimate the median duration.
Outcome measures
| Measure |
Cabozantinib
n=682 Participants
Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.
Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily.
|
Prednisone
n=346 Participants
Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.
Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
5.6 months
Interval 5.49 to 5.62
|
2.8 months
Interval 2.79 to 2.86
|
Adverse Events
Cabozantinib
Serious events: 420 serious events
Other events: 675 other events
Deaths: 0 deaths
Prednisone
Serious events: 181 serious events
Other events: 332 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cabozantinib
n=681 participants at risk
Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.
Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily.
|
Prednisone
n=342 participants at risk
Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.
Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.7%
32/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
4.7%
16/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.44%
3/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.58%
2/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.88%
6/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
1.2%
4/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Cardiac disorders
Acute coronary syndrome
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.73%
5/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Cardiac disorders
Angina pectoris
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Cardiac disorders
Arrhythmia
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Cardiac disorders
Atrial fibrillation
|
0.73%
5/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.58%
2/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Cardiac disorders
Atrioventricular block complete
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Cardiac disorders
Cardiac failure
|
0.59%
4/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Cardiac disorders
Myocardial infarction
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Congenital, familial and genetic disorders
Cystic lymphangioma
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Congenital, familial and genetic disorders
Metabolic myopathy
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Ear and labyrinth disorders
Vertigo
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Endocrine disorders
Adrenal insufficiency
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Endocrine disorders
Cushing's syndrome
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Endocrine disorders
Hypoaldosteronism
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Eye disorders
Diplopia
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Eye disorders
Visual acuity reduced
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
8/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.88%
3/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Anal fissure
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Anal fistula
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Anal inflammation
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Ascites
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Constipation
|
1.8%
12/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
1.8%
6/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
10/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.58%
2/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Dysphagia
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Faecaloma
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Gastric antral vascular estasia
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.44%
3/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Haematemesis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.44%
3/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Nausea
|
3.4%
23/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
1.8%
6/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Small intestinal obstrucion
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Stomatitis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Vomiting
|
4.1%
28/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
1.8%
6/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Asthenia
|
2.6%
18/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.88%
3/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Chest pain
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Death
|
0.59%
4/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Device dislocation
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Device occlusion
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Drug withdrawal syndrome
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Euthanasia
|
0.44%
3/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Fatigue
|
2.9%
20/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.88%
3/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
General physical health deterioration
|
7.6%
52/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
6.4%
22/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Influenza like illness
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Local swelling
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Malaise
|
0.73%
5/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Mucosal inflammation
|
1.2%
8/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Multi-organ failure
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.58%
2/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Non-cardiac chest pain
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Oedema peripheral
|
0.44%
3/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Pain
|
1.5%
10/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
2.0%
7/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Performance status decreased
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Pyrexia
|
2.2%
15/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
1.8%
6/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Sudden death
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Hepatobiliary disorders
Hepatic failure
|
0.44%
3/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Hepatobiliary disorders
Hepatitis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Hepatobiliary disorders
Jaundice
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Abdominal sepsis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Abscess
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Anal abscess
|
0.59%
4/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Appendicitis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Arthritis infective
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Aspergillus infection
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Cellulitis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Clostridium difficile colitis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Colonic abscess
|
0.44%
3/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Cystitis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Device related infection
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.58%
2/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Device related sepsis
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Endocarditis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Enterobacter infection
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Enterobactar sepsis
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Enterococcal sepsis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Erysipelas
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Gastroenteritis
|
0.44%
3/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Gastrointestinal infection
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Herpes simplex
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Herpes zoster
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Localised infection
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Lung infection
|
0.73%
5/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Neutropenic sepsis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Oral candidiasis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Osteomyelilitis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Otitis externa
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Periorbital cellulitis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Pharyngeal abscess
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Pilonidal cyst
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Pneumonia
|
2.5%
17/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
3.5%
12/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Pneumonia klebsiella
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Post procedural infection
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Pulmonary sepsis
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Pyelonephritis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Pyelonephritis acute
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Respiratory tract infection
|
0.44%
3/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Sepsis
|
1.6%
11/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
1.5%
5/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Septic shock
|
0.44%
3/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.58%
2/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Sinusitis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Spinal cord infection
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
1.5%
5/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Staphylococcal sepsis
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Streptococcal infection
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Subcutaneous abscess
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Tonsillitis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Tooth abscess
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Tracheobronchitis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Urinary tract infection
|
1.9%
13/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
1.8%
6/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Urosepsis
|
1.0%
7/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Viral infection
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Viral pharyngitis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Wound infection
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Injury, poisoning and procedural complications
Fall
|
0.44%
3/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Injury, poisoning and procedural complications
Keratorhexis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Injury, poisoning and procedural complications
Urostomy complication
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Investigations
Alanine aminotransferase increased
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Investigations
Aspartate aminotransferase increased
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Investigations
Blood bilirubin increased
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Investigations
Blood creatine increased
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Investigations
Clostridium test positive
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Investigations
Liver function test abnormal
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.58%
2/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Investigations
Platelet count decreased
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Investigations
Troponin T increased
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.2%
15/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.58%
2/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
20/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.58%
2/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Metabolism and nutrition disorders
Hyperglyceaemia
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.44%
3/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.73%
5/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.0%
7/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.44%
3/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.88%
6/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
1.2%
4/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
14/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
2.3%
8/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.2%
15/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
3.2%
11/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.59%
4/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.58%
2/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.44%
3/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.58%
2/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.58%
2/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.44%
3/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.59%
4/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.73%
5/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.59%
4/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
1.2%
4/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.58%
2/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hormone-refractory prostate cancer
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.73%
5/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.88%
3/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.58%
2/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
2.8%
19/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
3.5%
12/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodular melanoma
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
7.6%
52/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
7.9%
27/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second primary malignancy
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Cauda equina syndrome
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Cerebellar infarction
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Cerebral haematoma
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.44%
3/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Cerebral infarction
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Cerebral ischaemia
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.59%
4/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.88%
3/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Cognitive disorder
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Convulsion
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Dizziness
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Dyskinesia
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Facial paresis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Headache
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.88%
3/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Hypoaesthesia
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
1.2%
4/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Ischaemic stroke
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Lethargy
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Leukoencephalopathy
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Loss of consciousness
|
0.44%
3/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Nerve root compression
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Paraesthesia
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.58%
2/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Paralpegia
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.58%
2/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Parkinson's disease
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Presyncope
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Quadriparesis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Sciatica
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Sensorimotor disorder
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Somnolence
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Spinal cord compression
|
2.1%
14/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
2.3%
8/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Spinal cord paralysis
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Stupor
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Syncope
|
0.73%
5/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.58%
2/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Psychiatric disorders
Agitation
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Psychiatric disorders
Anxiety
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Psychiatric disorders
Confusional state
|
1.0%
7/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Psychiatric disorders
Delirium
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Psychiatric disorders
Depression
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Renal and urinary disorders
Bladder dysfunction
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Renal and urinary disorders
Calculus bladder
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Renal and urinary disorders
Haematuria
|
0.73%
5/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.88%
3/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.73%
5/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
1.2%
4/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Renal and urinary disorders
Hydroureter
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Renal and urinary disorders
Prerenal failure
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Renal and urinary disorders
Renal failure
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.88%
3/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Renal and urinary disorders
Renal failure acute
|
1.8%
12/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
1.2%
4/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Renal and urinary disorders
Renal impairment
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Renal and urinary disorders
Urethral obstruction
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Renal and urinary disorders
Urinary retention
|
1.0%
7/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.59%
4/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Reproductive system and breast disorders
Penile swelling
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Reproductive system and breast disorders
Scrotal swelling
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
10/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.88%
3/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.73%
5/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.58%
2/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
9/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.88%
3/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.59%
4/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
6.2%
42/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.88%
3/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.44%
3/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.44%
3/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Vascular disorders
Arterial occlusive disease
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Vascular disorders
Deep vein thrombosis
|
1.6%
11/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.88%
3/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Vascular disorders
Hypertension
|
1.0%
7/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.58%
2/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Vascular disorders
Hypertensive crisis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Vascular disorders
Hypotension
|
0.59%
4/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.58%
2/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Vascular disorders
Malignant hypertension
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Vascular disorders
Orthostatic hypotension
|
0.44%
3/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Vascular disorders
Venous haemorrhage
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Eye disorders
Uveitis
|
0.15%
1/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Radiculitis
|
0.00%
0/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Infection
|
0.29%
2/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.58%
2/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
Other adverse events
| Measure |
Cabozantinib
n=681 participants at risk
Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.
Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily.
|
Prednisone
n=342 participants at risk
Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.
Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
29.8%
203/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
32.5%
111/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.2%
42/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
5.8%
20/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Endocrine disorders
Hypothyroidism
|
13.8%
94/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.29%
1/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Abdominal pain
|
11.2%
76/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
4.7%
16/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.3%
43/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
4.7%
16/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Constipation
|
33.3%
227/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
29.2%
100/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Diarrhoea
|
51.2%
349/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
19.9%
68/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Dry mouth
|
9.5%
65/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
3.2%
11/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Dyspepsia
|
8.5%
58/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
1.8%
6/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Dysphagia
|
6.0%
41/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.00%
0/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.4%
37/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
2.0%
7/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Nausea
|
57.3%
390/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
29.8%
102/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Stomatits
|
18.6%
127/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
2.3%
8/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Gastrointestinal disorders
Vomiting
|
39.8%
271/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
19.6%
67/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Asthenia
|
33.5%
228/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
18.4%
63/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Fatigue
|
49.6%
338/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
34.8%
119/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
General physical health deterioration
|
6.9%
47/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
3.8%
13/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Muscosal inflammation
|
19.7%
134/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
2.6%
9/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Oedema peripheral
|
14.8%
101/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
12.6%
43/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Pain
|
8.2%
56/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
9.6%
33/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
General disorders
Pyrexia
|
9.8%
67/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
10.5%
36/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Infections and infestations
Urinary tract infection
|
10.4%
71/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
8.5%
29/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Investigations
Alanine aminotransferase increased
|
8.2%
56/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
2.9%
10/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Investigations
Aspartate aminotransferase increased
|
10.3%
70/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
4.1%
14/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Investigations
Weight decreased
|
34.8%
237/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
12.0%
41/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
59.8%
407/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
28.9%
99/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
38/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
4.4%
15/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.3%
50/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
5.8%
20/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.1%
69/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
2.6%
9/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.3%
36/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
0.88%
3/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.4%
91/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
14.6%
50/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.9%
115/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
18.7%
64/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.0%
109/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
18.4%
63/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.0%
48/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
5.8%
20/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
7.0%
48/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
6.4%
22/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.3%
43/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
10.8%
37/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.4%
98/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
10.5%
36/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Dizziness
|
7.0%
48/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
5.6%
19/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Dysgeusia
|
25.7%
175/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
4.7%
16/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Nervous system disorders
Headache
|
12.8%
87/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
4.1%
14/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Psychiatric disorders
Depression
|
6.2%
42/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
3.2%
11/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Psychiatric disorders
Insomnia
|
7.8%
53/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
8.2%
28/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.6%
52/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
4.4%
15/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
26.4%
180/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
6.1%
21/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.8%
135/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
13.5%
46/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.4%
37/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
2.6%
9/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.8%
53/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
2.3%
8/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
29.4%
200/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
1.5%
5/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Vascular disorders
Hypertension
|
28.0%
191/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
11.1%
38/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
|
Vascular disorders
Hypotension
|
5.3%
36/681 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
3.8%
13/342 • Up to 92 weeks
Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreements with investigators vary; constant is our right to review results communications prior to public release, and embargo communications for a period of ≤60 days from submittal for review. We do not prohibit investigators from publishing, but we may require previously undisclosed confidential information, other than study results, to be removed from publications, and single-center publications are postponed until after publication of the trial's primary multicenter publication.
- Publication restrictions are in place
Restriction type: OTHER