Trial Outcomes & Findings for Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy (NCT NCT03755791)
NCT ID: NCT03755791
Last Updated: 2025-12-11
Results Overview
PFS was defined as the time from randomization to the earlier of either the date of radiographic progression defined as a 20% increase in the sum of the longest diameters of target lesions, or the unequivocal appearance of new lesions, or progression of non-target disease per Blinded Independent Radiology Committee (BIRC) or the date of death due to any cause per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
837 participants
Primary outcome timeframe
From the date of first participant randomization up to 28 months
Results posted on
2025-12-11
Participant Flow
Participant milestones
| Measure |
Experimental Arm: Cabozantinib + Atezolizumab
Participants received 40 milligrams (mg) cabozantinib oral tablets once daily + 1200 mg intravenous (IV) infusion of atezolizumab once every 3 weeks for up to 38 months.
|
Single-Agent Cabozantinib
Participants received 60 mg cabozantinib oral tablets once daily for up to 38 months.
|
Control Arm: Sorafenib
Participants received 400 mg sorafenib oral tablets twice daily (BID) for up to 38 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
432
|
188
|
217
|
|
Overall Study
Received At Least 1 Dose of Study Drug
|
429
|
188
|
207
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
432
|
188
|
217
|
Reasons for withdrawal
| Measure |
Experimental Arm: Cabozantinib + Atezolizumab
Participants received 40 milligrams (mg) cabozantinib oral tablets once daily + 1200 mg intravenous (IV) infusion of atezolizumab once every 3 weeks for up to 38 months.
|
Single-Agent Cabozantinib
Participants received 60 mg cabozantinib oral tablets once daily for up to 38 months.
|
Control Arm: Sorafenib
Participants received 400 mg sorafenib oral tablets twice daily (BID) for up to 38 months.
|
|---|---|---|---|
|
Overall Study
Did not receive any study treatment
|
3
|
0
|
10
|
|
Overall Study
Radiographic progression
|
204
|
92
|
115
|
|
Overall Study
Adverse Event
|
140
|
60
|
51
|
|
Overall Study
Lack of Efficacy
|
12
|
6
|
6
|
|
Overall Study
Withdrawal by Subject
|
26
|
23
|
24
|
|
Overall Study
Sponsor decision,
|
41
|
5
|
7
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
0
|
2
|
|
Overall Study
Other than specified
|
5
|
2
|
0
|
Baseline Characteristics
Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy
Baseline characteristics by cohort
| Measure |
Experimental Arm: Cabozantinib + Atezolizumab
n=432 Participants
Participants received 40 mg cabozantinib oral tablets once daily + 1200 mg IV infusion of atezolizumab once every 3 weeks for up to 38 months.
|
Single-Agent Cabozantinib
n=188 Participants
Participants received 60 mg cabozantinib oral tablets once daily for up to 38 months.
|
Control Arm: Sorafenib
n=217 Participants
Participants received 400 mg sorafenib oral tablets twice daily for up to 38 months.
|
Total
n=837 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
234 Participants
n=9 Participants
|
97 Participants
n=6 Participants
|
112 Participants
n=9 Participants
|
443 Participants
n=205 Participants
|
|
Age, Categorical
>=65 years
|
198 Participants
n=9 Participants
|
91 Participants
n=6 Participants
|
105 Participants
n=9 Participants
|
394 Participants
n=205 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=9 Participants
|
30 Participants
n=6 Participants
|
31 Participants
n=9 Participants
|
133 Participants
n=205 Participants
|
|
Sex: Female, Male
Male
|
360 Participants
n=9 Participants
|
158 Participants
n=6 Participants
|
186 Participants
n=9 Participants
|
704 Participants
n=205 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
42 Participants
n=9 Participants
|
21 Participants
n=6 Participants
|
15 Participants
n=9 Participants
|
78 Participants
n=205 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
352 Participants
n=9 Participants
|
158 Participants
n=6 Participants
|
183 Participants
n=9 Participants
|
693 Participants
n=205 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
38 Participants
n=9 Participants
|
9 Participants
n=6 Participants
|
19 Participants
n=9 Participants
|
66 Participants
n=205 Participants
|
|
Race/Ethnicity, Customized
Asian
|
127 Participants
n=9 Participants
|
64 Participants
n=6 Participants
|
72 Participants
n=9 Participants
|
263 Participants
n=205 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
8 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
14 Participants
n=205 Participants
|
|
Race/Ethnicity, Customized
White
|
217 Participants
n=9 Participants
|
95 Participants
n=6 Participants
|
111 Participants
n=9 Participants
|
423 Participants
n=205 Participants
|
|
Race/Ethnicity, Customized
Other than specified
|
80 Participants
n=9 Participants
|
24 Participants
n=6 Participants
|
33 Participants
n=9 Participants
|
137 Participants
n=205 Participants
|
PRIMARY outcome
Timeframe: From the date of first participant randomization up to 28 monthsPopulation: PITT population included the first 372 participants randomized to the experimental (cabozantinib + atezolizumab) arm and control (sorafenib) arm.
PFS was defined as the time from randomization to the earlier of either the date of radiographic progression defined as a 20% increase in the sum of the longest diameters of target lesions, or the unequivocal appearance of new lesions, or progression of non-target disease per Blinded Independent Radiology Committee (BIRC) or the date of death due to any cause per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Outcome measures
| Measure |
Experimental Arm: Cabozantinib + Atezolizumab
n=250 Participants
Participants received 40 mg cabozantinib oral tablets once daily + 1200 mg IV infusion of atezolizumab once every 3 weeks for up to 38 months.
|
Control Arm: Sorafenib
n=122 Participants
Participants received 400 mg sorafenib oral tablets twice daily for up to 38 months.
|
|---|---|---|
|
Progression Free Survival (PFS) for the Experimental Arm Versus the Control Arm in the PFS Intent to Treat (PITT) Population
|
6.80 months
Interval 5.55 to 8.34
|
4.21 months
Interval 2.79 to 7.03
|
PRIMARY outcome
Timeframe: From the date of first participant randomization up to 36 monthsPopulation: ITT population included all participants randomized to the experimental (cabozantinib + atezolizumab) arm and control (sorafenib) arm.
OS was defined as the time from randomization to death due to any cause.
Outcome measures
| Measure |
Experimental Arm: Cabozantinib + Atezolizumab
n=432 Participants
Participants received 40 mg cabozantinib oral tablets once daily + 1200 mg IV infusion of atezolizumab once every 3 weeks for up to 38 months.
|
Control Arm: Sorafenib
n=217 Participants
Participants received 400 mg sorafenib oral tablets twice daily for up to 38 months.
|
|---|---|---|
|
Overall Survival (OS) for the Experimental Arm Versus the Control Arm in the ITT Population
|
16.46 months
Interval 14.46 to 18.56
|
15.51 months
Interval 12.19 to 19.98
|
SECONDARY outcome
Timeframe: From the date of first participant randomization up to 28 monthsPopulation: ITT population included all participants randomized to the single agent cabozantinib arm and control (sorafenib) arm.
PFS was defined as the time from randomization to the earlier of either the date of radiographic progression per BIRC or the date of death due to any cause per RECIST version 1.1.
Outcome measures
| Measure |
Experimental Arm: Cabozantinib + Atezolizumab
n=188 Participants
Participants received 40 mg cabozantinib oral tablets once daily + 1200 mg IV infusion of atezolizumab once every 3 weeks for up to 38 months.
|
Control Arm: Sorafenib
n=217 Participants
Participants received 400 mg sorafenib oral tablets twice daily for up to 38 months.
|
|---|---|---|
|
PFS for the Single-Agent Cabozantinib Arm Versus the Control Arm in the ITT Population
|
5.82 months
Interval 5.42 to 8.18
|
4.27 months
Interval 2.86 to 6.11
|
Adverse Events
Experimental Arm: Cabozantinib + Atezolizumab
Serious events: 226 serious events
Other events: 414 other events
Deaths: 307 deaths
Single-Agent Cabozantinib
Serious events: 88 serious events
Other events: 182 other events
Deaths: 135 deaths
Control Arm: Sorafenib
Serious events: 85 serious events
Other events: 202 other events
Deaths: 141 deaths
Serious adverse events
| Measure |
Experimental Arm: Cabozantinib + Atezolizumab
n=429 participants at risk
Participants received 40 mg cabozantinib oral tablets once daily + 1200 mg IV infusion of atezolizumab once every 3 weeks for up to 38 months.
|
Single-Agent Cabozantinib
n=188 participants at risk
Participants received 60 mg cabozantinib oral tablets once daily for up to 38 months.
|
Control Arm: Sorafenib
n=207 participants at risk
Participants received 400 mg sorafenib oral tablets twice daily for up to 38 months.
|
|---|---|---|---|
|
General disorders
Chest pain
|
0.70%
3/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
General disorders
Death
|
0.93%
4/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
General disorders
Fatigue
|
0.47%
2/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.1%
2/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
6/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.9%
4/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
5/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Cardiac disorders
Atrial fibrillation
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Cardiac disorders
Cardiac arrest
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Cardiac disorders
Pericardial effusion
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Cardiac disorders
Tachycardia
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.70%
3/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Endocrine disorders
Hyperthyroidism
|
0.47%
2/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Endocrine disorders
Thyroiditis
|
0.47%
2/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Eye disorders
Visual impairment
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
8/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
2.1%
4/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.9%
4/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.93%
4/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Anal fistula
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Ascites
|
3.5%
15/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.6%
3/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.4%
3/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Colitis
|
0.93%
4/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Constipation
|
0.70%
3/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
9/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
2.1%
4/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Dysphagia
|
0.47%
2/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Enteritis
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Gastritis
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.70%
3/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.6%
3/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.4%
3/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.93%
4/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Nausea
|
0.47%
2/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.1%
2/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.93%
4/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.1%
2/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.97%
2/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.70%
3/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.1%
2/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.93%
4/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.97%
2/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Visceral venous thrombosis
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.1%
2/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
5/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.6%
3/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
General disorders
Abscess sterile
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
General disorders
Asthenia
|
1.6%
7/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.1%
2/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.97%
2/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
General disorders
General physical health deterioration
|
1.2%
5/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.97%
2/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
General disorders
Generalised oedema
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
General disorders
Inflammation
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
General disorders
Influenza like illness
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
General disorders
Malaise
|
0.47%
2/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
General disorders
Mucosal inflammation
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.93%
4/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
General disorders
Non-cardiac chest pain
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
General disorders
Oedema peripheral
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
General disorders
Pyrexia
|
2.6%
11/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
General disorders
Sudden death
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.1%
2/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.47%
2/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Hepatobiliary disorders
Biloma
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Hepatobiliary disorders
Cholangitis
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Hepatobiliary disorders
Chronic hepatic failure
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.47%
2/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.1%
2/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.9%
8/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
2.1%
4/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.97%
2/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Hepatobiliary disorders
Hepatitis
|
0.47%
2/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.47%
2/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.47%
2/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Immune system disorders
Hypersensitivity
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Abscess limb
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Acute sinusitis
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Anal abscess
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.1%
2/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Bacterial diarrhoea
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Biliary tract infection
|
0.47%
2/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.97%
2/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Bronchitis
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
COVID-19
|
2.8%
12/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.6%
3/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.97%
2/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Cellulitis
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.97%
2/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Cholangitis infective
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Cystitis
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Enterocolitis bacterial
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Eye infection bacterial
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Gastroenteritis
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Gastroenteritis viral
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Groin abscess
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Hepatic infection
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Infection
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Klebsiella sepsis
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Localised infection
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Osteomyelitis
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Periodontitis
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Peritonitis bacterial
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Pneumonia
|
1.6%
7/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
2.1%
4/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.4%
3/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Pneumonia moraxella
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Salmonella bacteraemia
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Sepsis
|
2.6%
11/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
2.1%
4/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.97%
2/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Septic shock
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Skin infection
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Urinary tract infection
|
1.6%
7/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Urosepsis
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Wound infection
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Injury, poisoning and procedural complications
Hepatic rupture
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Alanine aminotransferase increased
|
1.9%
8/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.1%
2/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Amylase increased
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Aspartate aminotransferase increased
|
2.1%
9/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.1%
2/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Blood bilirubin increased
|
0.70%
3/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Blood thyroid stimulating hormone abnormal
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Electrocardiogram abnormal
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Lipase increased
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Liver function test abnormal
|
0.93%
4/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Liver function test increased
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Neutrophil count decreased
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Platelet count decreased
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Transaminases increased
|
0.70%
3/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Weight decreased
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
White blood cell count decreased
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.93%
4/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.47%
2/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.1%
2/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.47%
2/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.47%
2/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.47%
2/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.93%
4/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.6%
3/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
8.9%
38/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
13.8%
26/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
8.7%
18/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal squamous cell carcinoma
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.6%
3/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.97%
2/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Vascular disorders
Embolism
|
0.47%
2/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour rupture
|
0.47%
2/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Nervous system disorders
Brain compression
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Nervous system disorders
Cerebral venous sinus thrombosis
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Nervous system disorders
Encephalopathy
|
0.70%
3/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Nervous system disorders
Headache
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Nervous system disorders
Hepatic encephalopathy
|
2.8%
12/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
3.7%
7/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Nervous system disorders
Ischaemic stroke
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Nervous system disorders
Parkinson's disease
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Nervous system disorders
Syncope
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Nervous system disorders
Vertebrobasilar stroke
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
6/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
2.1%
4/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.9%
4/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Renal and urinary disorders
Proteinuria
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Renal and urinary disorders
Renal failure
|
0.47%
2/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Renal and urinary disorders
Renal impairment
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Renal and urinary disorders
Urinary retention
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/360 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.63%
1/158 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/186 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.70%
3/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.47%
2/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated pneumonitis
|
0.70%
3/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.47%
2/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.9%
8/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.1%
2/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity vasculitis
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Surgical and medical procedures
Catheterisation venous
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Surgical and medical procedures
Renal stone removal
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Vascular disorders
Bleeding varicose vein
|
0.47%
2/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Vascular disorders
Embolism arterial
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Vascular disorders
Hypertension
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Vascular disorders
Hypertensive crisis
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Vascular disorders
Hypotension
|
0.70%
3/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Vascular disorders
Hypovolaemic shock
|
0.70%
3/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.53%
1/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Vascular disorders
Thrombosis
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.48%
1/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Vascular disorders
Venous thrombosis
|
0.23%
1/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.00%
0/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
Other adverse events
| Measure |
Experimental Arm: Cabozantinib + Atezolizumab
n=429 participants at risk
Participants received 40 mg cabozantinib oral tablets once daily + 1200 mg IV infusion of atezolizumab once every 3 weeks for up to 38 months.
|
Single-Agent Cabozantinib
n=188 participants at risk
Participants received 60 mg cabozantinib oral tablets once daily for up to 38 months.
|
Control Arm: Sorafenib
n=207 participants at risk
Participants received 400 mg sorafenib oral tablets twice daily for up to 38 months.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
50.1%
215/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
54.3%
102/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
47.3%
98/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
24/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
7.4%
14/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
2.9%
6/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.0%
13/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
5.3%
10/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.9%
4/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Nausea
|
16.3%
70/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
21.3%
40/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
14.5%
30/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Stomatitis
|
9.3%
40/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
13.3%
25/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
3.9%
8/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Vomiting
|
10.5%
45/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
18.1%
34/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
7.2%
15/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Endocrine disorders
Hypothyroidism
|
21.7%
93/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
19.1%
36/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
4.3%
9/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.9%
68/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
13.3%
25/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
18.4%
38/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.2%
35/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
10.6%
20/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
8.2%
17/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Ascites
|
12.6%
54/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
12.8%
24/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
6.8%
14/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Gastrointestinal disorders
Constipation
|
15.2%
65/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
17.6%
33/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
11.1%
23/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Blood and lymphatic system disorders
Anaemia
|
12.8%
55/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
12.2%
23/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
11.6%
24/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.6%
37/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
8.5%
16/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
3.4%
7/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
43/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
11.7%
22/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
5.3%
11/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
General disorders
Asthenia
|
21.2%
91/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
18.1%
34/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
17.9%
37/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
General disorders
Fatigue
|
26.3%
113/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
31.9%
60/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
17.4%
36/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
General disorders
Mucosal inflammation
|
11.0%
47/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
11.2%
21/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
5.8%
12/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
General disorders
Oedema peripheral
|
12.4%
53/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
11.7%
22/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
7.2%
15/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
General disorders
Pyrexia
|
11.9%
51/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
12.2%
23/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
12.6%
26/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.1%
22/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
2.7%
5/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.97%
2/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Infections and infestations
Urinary tract infection
|
8.4%
36/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
6.4%
12/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
2.9%
6/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Alanine aminotransferase increased
|
31.2%
134/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
29.8%
56/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
11.6%
24/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Amylase increased
|
8.6%
37/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
5.9%
11/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
4.8%
10/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Aspartate aminotransferase increased
|
32.2%
138/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
32.4%
61/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
14.5%
30/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.9%
34/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
9.6%
18/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
6.3%
13/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Blood bilirubin increased
|
13.8%
59/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
14.4%
27/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
11.6%
24/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.1%
22/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
4.8%
9/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
3.9%
8/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
5.1%
22/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
8.5%
16/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.97%
2/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.9%
34/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
7.4%
14/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
6.3%
13/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Lipase increased
|
10.5%
45/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
4.3%
8/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
4.8%
10/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Neutrophil count decreased
|
6.3%
27/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
5.9%
11/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
0.97%
2/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Platelet count decreased
|
13.8%
59/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
14.4%
27/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
6.3%
13/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
Weight decreased
|
19.1%
82/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
25.5%
48/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
15.9%
33/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Investigations
White blood cell count decreased
|
3.7%
16/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
5.9%
11/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.9%
4/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
29.8%
128/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
43.1%
81/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
20.8%
43/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
9.6%
41/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
6.9%
13/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
6.8%
14/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.3%
40/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
6.4%
12/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
5.8%
12/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.1%
26/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
6.9%
13/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.4%
3/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.2%
31/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
7.4%
14/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
4.3%
9/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.1%
22/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
5.3%
10/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
4.3%
9/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.9%
34/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
5.9%
11/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
5.8%
12/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.8%
29/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
4.8%
9/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
6.8%
14/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.8%
29/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
5.3%
10/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
3.9%
8/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.5%
32/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
3.7%
7/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.9%
4/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Nervous system disorders
Dizziness
|
5.4%
23/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
6.4%
12/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
3.4%
7/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Nervous system disorders
Dysgeusia
|
9.1%
39/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
9.0%
17/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.4%
3/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Nervous system disorders
Headache
|
7.9%
34/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
5.3%
10/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
3.4%
7/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Psychiatric disorders
Insomnia
|
7.0%
30/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
5.3%
10/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
3.9%
8/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Renal and urinary disorders
Proteinuria
|
9.3%
40/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
10.1%
19/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
6.8%
14/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.6%
41/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
4.3%
8/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
6.8%
14/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
12.1%
52/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
17.6%
33/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
6.8%
14/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.2%
31/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
4.8%
9/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
4.8%
10/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.1%
22/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
5.3%
10/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
1.9%
4/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.4%
23/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
6.4%
12/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
2.4%
5/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.5%
15/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
7.4%
14/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
15.0%
31/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.9%
38/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
8.0%
15/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
3.9%
8/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
43.1%
185/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
43.6%
82/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
44.4%
92/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.0%
47/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
6.4%
12/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
6.8%
14/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.9%
64/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
15.4%
29/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
18.4%
38/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
|
Vascular disorders
Hypertension
|
24.7%
106/429 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
29.8%
56/188 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
18.8%
39/207 • Up to 39 months
Safety population included all randomized participants who received at least one dose of study drug. The participants that did not receive any medication in the Cabozantinib + Atezolizumab and the Sorafenib were not included in the safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place