Trial Outcomes & Findings for Vemurafenib, Cobimetinib, Atezolizumab, and Tiragolumab in Treating Patients With High-Risk Stage III Melanoma (NCT NCT03554083)

Last Updated: 2026-05-04

Results Overview

Pathologic complete response rate defined as the percentage of patients with no residual disease found in the surgical specimen among the patients who began neo-adjuvant protocol treatment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

64 participants

Primary outcome timeframe

12 weeks

Results posted on

2026-05-04

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A Patients receive vemurafenib PO BID on days 1-28 and cobimetinib PO QD on days 1-21. Patients also receive atezolizumab intravenously (IV) over 30-60 minutes on days 1 and 15 of cycles 2 and 3. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. \> Within 2-4 weeks after treatment, patients undergo surgery then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.	Arm B Patients receive cobimetinib as in Arm A and atezolizumab IV over 30-60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-4 weeks after treatment, patients undergo surgery then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.	Arm C Patients with BRAF wild-type or BRAF mutant melanoma receive atezolizumab IV over 30-60 minutes and tiragolumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Neo-Adjuvant STARTED	15	15	34
Neo-Adjuvant COMPLETED	15	15	34
Neo-Adjuvant NOT COMPLETED	0	0	0
Surgery STARTED	15	15	34
Surgery COMPLETED	15	13	30
Surgery NOT COMPLETED	0	2	4
Adjuvant STARTED	15	13	30
Adjuvant COMPLETED	14	13	28
Adjuvant NOT COMPLETED	1	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vemurafenib, Cobimetinib, Atezolizumab, and Tiragolumab in Treating Patients With High-Risk Stage III Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A - (Vemurafenib, Cobimetinib, Atezolizumab) n=15 Participants Patients receive vemurafenib PO BID on days 1-28 and cobimetinib PO QD on days 1-21. Patients also receive atezolizumab intravenously (IV) over 30-60 minutes on days 1 and 15 of cycles 2 and 3. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.\> Within 2-4 weeks after treatment, patients undergo surgery then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.	Arm B - (Cobimetinib, Atezolizumab) n=15 Participants Patients receive cobimetinib as in Arm A and atezolizumab IV over 30-60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-4 weeks after treatment, patients undergo surgery then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.	Arm C (Atezolizumab, Tiragolumab) n=34 Participants Patients with BRAF wild-type or BRAF mutant melanoma receive atezolizumab IV over 30-60 minutes and tiragolumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.	Total n=64 Participants Total of all reporting groups
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants	0 Participants n=1 Participants
Race (NIH/OMB) Asian	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants	0 Participants n=1 Participants
Age, Continuous	56 years n=54 Participants	66 years n=60 Participants	59 years n=114 Participants	59 years n=1 Participants
Sex: Female, Male Female	9 Participants n=54 Participants	10 Participants n=60 Participants	14 Participants n=114 Participants	33 Participants n=1 Participants
Sex: Female, Male Male	6 Participants n=54 Participants	5 Participants n=60 Participants	20 Participants n=114 Participants	31 Participants n=1 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants	0 Participants n=1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=54 Participants	15 Participants n=60 Participants	34 Participants n=114 Participants	64 Participants n=1 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants	0 Participants n=1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants	0 Participants n=1 Participants
Race (NIH/OMB) Black or African American	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants	0 Participants n=1 Participants
Race (NIH/OMB) White	15 Participants n=54 Participants	15 Participants n=60 Participants	34 Participants n=114 Participants	64 Participants n=1 Participants
Race (NIH/OMB) More than one race	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants	0 Participants n=1 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants	0 Participants n=1 Participants

PRIMARY outcome

Timeframe: 12 weeks

Pathologic complete response rate defined as the percentage of patients with no residual disease found in the surgical specimen among the patients who began neo-adjuvant protocol treatment.

Outcome measures

Outcome measures
Measure	Arm A n=15 Participants Patients receive vemurafenib PO BID on days 1-28 and cobimetinib PO QD on days 1-21. Patients also receive atezolizumab intravenously (IV) over 30-60 minutes on days 1 and 15 of cycles 2 and 3. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-4 weeks after treatment, patients undergo surgery then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.	Arm B n=15 Participants Patients receive cobimetinib as in Arm A and atezolizumab IV over 30-60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-4 weeks after treatment, patients undergo surgery then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Within 2-4 weeks after treatment, patients undergo surgery then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.	Arm C n=34 Participants Patients with BRAF wild-type or BRAF mutant melanoma receive atezolizumab IV over 30-60 minutes and tiragolumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 2-4 weeks after treatment, patients undergo surgery then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Pathologic Complete Response Rate (pCR)	66.7 percentage of participants	13.3 percentage of participants	38.2 percentage of participants

PRIMARY outcome

Timeframe: 3 years

Recurrence-free survival is defined as the time from surgery to radiographic or histologic evidence of local, regional, or distant recurrence of melanoma or death due to any cause. For each regimen, the distribution of recurrence-free survival times \[denoted as RFS(t)\] will be estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Arm A n=14 Participants Patients receive vemurafenib PO BID on days 1-28 and cobimetinib PO QD on days 1-21. Patients also receive atezolizumab intravenously (IV) over 30-60 minutes on days 1 and 15 of cycles 2 and 3. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-4 weeks after treatment, patients undergo surgery then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.	Arm B n=13 Participants Patients receive cobimetinib as in Arm A and atezolizumab IV over 30-60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-4 weeks after treatment, patients undergo surgery then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Within 2-4 weeks after treatment, patients undergo surgery then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.	Arm C n=28 Participants Patients with BRAF wild-type or BRAF mutant melanoma receive atezolizumab IV over 30-60 minutes and tiragolumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 2-4 weeks after treatment, patients undergo surgery then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Median Recurrence-free (RFS) Rate (Adjuvant Phase)	NA months Interval 18.9 to Too few events to calculate	40.8 months Interval 13.1 to Too few events to calculate	NA months Too few events to calculate

SECONDARY outcome

Timeframe: 14 months

Population: All patients that began treatment.

For each cohort, the frequency and severity of toxicities will be documented using the CTCAE criteria. The number of patients experiencing grade 3 or higher events, regardless of attribution, will be reported.

Outcome measures

Outcome measures
Measure	Arm A n=15 Participants Patients receive vemurafenib PO BID on days 1-28 and cobimetinib PO QD on days 1-21. Patients also receive atezolizumab intravenously (IV) over 30-60 minutes on days 1 and 15 of cycles 2 and 3. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-4 weeks after treatment, patients undergo surgery then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.	Arm B n=15 Participants Patients receive cobimetinib as in Arm A and atezolizumab IV over 30-60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-4 weeks after treatment, patients undergo surgery then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Within 2-4 weeks after treatment, patients undergo surgery then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.	Arm C n=34 Participants Patients with BRAF wild-type or BRAF mutant melanoma receive atezolizumab IV over 30-60 minutes and tiragolumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 2-4 weeks after treatment, patients undergo surgery then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE)	12 Participants	9 Participants	10 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Stratified Cox modeling will be conducted with participant cohort as the strata to obtain a point and interval estimate of the hazard of recurrence among those with biomarker levels thought to be delirious relative to the hazard of recurrence among those with biomarker levels thought not to be delirious.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Graphs will be constructed to visually compare and contrast the levels of these biomarkers between those who achieve a pCR and those who did not. Binomial confidence intervals for the difference in two independent proportions or t confidence intervals for the difference in two independent means will be used to gain preliminary insights into the difference in these biomarkers among those who achieve a pCR and those who did not.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Will be correlated with pCR. Graphs will be constructed to visually compare and contrast the level of tumor DNA between those who achieve a pCR and those who do not.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

A waterfall plot of the percent change will be constructed by pCR status. A two sample Wilcoxon rank sum test will be used to assess whether the percent change in intra-tumoral T cells from the primary lesion or in peripheral blood T cells differ among those who have a pCR and those who do not. Also, the proportion of patients who have a change in intra-tumoral T cell clonality and the proportion of patients who have a change in peripheral blood T cell clonality will be determined. For each of these parameters, a 95% binomial confidence interval for the difference in the parameter between those who have a pCR and those who do not will be constructed. Finally, the ratio of the intra-tumoral T cell clonality in the involved lymph node to the intra-tumoral T cell clonality in the uninvolved lymph node will be determined. This ratio will be summarized descriptively using median and inter-quartile range.

Outcome measures

Outcome data not reported

Adverse Events

Arm A - (Vemurafenib, Cobimetinib, Atezolizumab)

Serious events: 7 serious events

Other events: 15 other events

Deaths: 2 deaths

Arm B - (Cobimetinib, Atezolizumab)

Serious events: 4 serious events

Other events: 15 other events

Deaths: 6 deaths

Arm C (Atezolizumab, Tiragolumab)

Serious events: 10 serious events

Other events: 33 other events

Deaths: 7 deaths

Serious adverse events

Other adverse events

Additional Information

Matthew Block

Mayo Clinic

Phone: 507-293-0553

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm A - (Vemurafenib, Cobimetinib, Atezolizumab) n=15 participants at risk Within 2-4 weeks after treatment, patients undergo surgery then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.	Arm B - (Cobimetinib, Atezolizumab) n=15 participants at risk Patients receive cobimetinib as in Arm A and atezolizumab IV over 30-60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-4 weeks after treatment, patients undergo surgery then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.	Arm C (Atezolizumab, Tiragolumab) n=34 participants at risk Patients with BRAF wild-type or BRAF mutant melanoma receive atezolizumab IV over 30-60 minutes and tiragolumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Immune system disorders Cytokine release syndrome	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	2.9% 1/34 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months
Infections and infestations Pelvic infection	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	2.9% 1/34 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months
Infections and infestations Sepsis	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	2.9% 1/34 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months
Infections and infestations Skin infection	6.7% 1/15 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	2.9% 1/34 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	2.9% 1/34 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months
Metabolism and nutrition disorders Hyperglycemia	6.7% 1/15 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/34 • Adverse events were followed for 14 months and mortality was followed for 66 months
Investigations Alanine aminotransferase increased	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	2.9% 1/34 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months
Investigations Aspartate aminotransferase increased	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	2.9% 1/34 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months
Investigations CPK increased	6.7% 1/15 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/34 • Adverse events were followed for 14 months and mortality was followed for 66 months
Investigations White blood cell decreased	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	2.9% 1/34 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months
Metabolism and nutrition disorders Dehydration	6.7% 1/15 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/34 • Adverse events were followed for 14 months and mortality was followed for 66 months
Infections and infestations Infections and infestations - Oth spec	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	13.3% 2/15 • Number of events 2 • Adverse events were followed for 14 months and mortality was followed for 66 months	2.9% 1/34 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	6.7% 1/15 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/34 • Adverse events were followed for 14 months and mortality was followed for 66 months
Infections and infestations Joint infection	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	2.9% 1/34 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months
Infections and infestations Lung infection	6.7% 1/15 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/34 • Adverse events were followed for 14 months and mortality was followed for 66 months
Vascular disorders Thromboembolic event	6.7% 1/15 • Number of events 2 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/34 • Adverse events were followed for 14 months and mortality was followed for 66 months
Blood and lymphatic system disorders Anemia	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	2.9% 1/34 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months
Endocrine disorders Adrenal insufficiency	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	2.9% 1/34 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months
Eye disorders Uveitis	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	2.9% 1/34 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months
Gastrointestinal disorders Diarrhea	6.7% 1/15 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/34 • Adverse events were followed for 14 months and mortality was followed for 66 months
Immune system disorders Autoimmune disorder	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	2.9% 1/34 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months
Musculoskeletal and connective tissue disorders Arthralgia	13.3% 2/15 • Number of events 2 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/34 • Adverse events were followed for 14 months and mortality was followed for 66 months
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	6.7% 1/15 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/34 • Adverse events were followed for 14 months and mortality was followed for 66 months
Musculoskeletal and connective tissue disorders Myalgia	6.7% 1/15 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/34 • Adverse events were followed for 14 months and mortality was followed for 66 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	2.9% 1/34 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months
Nervous system disorders Headache	6.7% 1/15 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/34 • Adverse events were followed for 14 months and mortality was followed for 66 months
Respiratory, thoracic and mediastinal disorders Hypoxia	6.7% 1/15 • Number of events 2 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/34 • Adverse events were followed for 14 months and mortality was followed for 66 months
Respiratory, thoracic and mediastinal disorders Pneumonitis	6.7% 1/15 • Number of events 2 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/34 • Adverse events were followed for 14 months and mortality was followed for 66 months
Skin and subcutaneous tissue disorders Rash maculo-papular	6.7% 1/15 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/34 • Adverse events were followed for 14 months and mortality was followed for 66 months
Vascular disorders Hypertension	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	6.7% 1/15 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/34 • Adverse events were followed for 14 months and mortality was followed for 66 months
Vascular disorders Lymphocele	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	0.00% 0/15 • Adverse events were followed for 14 months and mortality was followed for 66 months	2.9% 1/34 • Number of events 1 • Adverse events were followed for 14 months and mortality was followed for 66 months