Trial Outcomes & Findings for Lenvatinib and Pembrolizumab in Differentiated Thyroid Cancers (DTC) (NCT NCT02973997)

NCT ID: NCT02973997

Last Updated: 2025-08-29

Results Overview

Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Will use a one-stage binomial design.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

57 participants

Primary outcome timeframe

26 months

Results posted on

2025-08-29

Participant Flow

Two patients enrolled in cohort 2 did not begin treatment; one withdrew prior to beginning protocol treatment, and the other was found to be ineligible and was removed prior to beginning treatment.

Participant milestones

Participant milestones
Measure	Cohort 1 Lenvatinib-naïve patients \> Patients receive lenvatinib 20mg PO QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 19 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment for up to 35 cycles. \> \> Laboratory Biomarker Analysis: Correlative studies \> \> Lenvatinib: Given PO \> \> Lenvatinib Mesylate: Given PO \> \> Pembrolizumab: Given IV	Cohort 2 Previously progressed on Lenvatinib alone \> Patients receive lenvatinib daily dose at progression QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 19 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment for up to 35 cycles. \> \> Laboratory Biomarker Analysis: Correlative studies \> \> Lenvatinib: Given PO \> \> Lenvatinib Mesylate: Given PO \> \> Pembrolizumab: Given IV
Overall Study STARTED	30	25
Overall Study COMPLETED	8	2
Overall Study NOT COMPLETED	22	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 Lenvatinib-naïve patients \> Patients receive lenvatinib 20mg PO QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 19 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment for up to 35 cycles. \> \> Laboratory Biomarker Analysis: Correlative studies \> \> Lenvatinib: Given PO \> \> Lenvatinib Mesylate: Given PO \> \> Pembrolizumab: Given IV	Cohort 2 Previously progressed on Lenvatinib alone \> Patients receive lenvatinib daily dose at progression QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 19 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment for up to 35 cycles. \> \> Laboratory Biomarker Analysis: Correlative studies \> \> Lenvatinib: Given PO \> \> Lenvatinib Mesylate: Given PO \> \> Pembrolizumab: Given IV
Overall Study Withdrawal by Subject	4	0
Overall Study Adverse Event	4	1
Overall Study Disease Progression	11	20
Overall Study Alternative Therapy	3	0
Overall Study Other complicating disease	0	1
Overall Study Death	0	1

Baseline Characteristics

Lenvatinib and Pembrolizumab in Differentiated Thyroid Cancers (DTC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=30 Participants Lenvatinib-naïve patients\> Patients receive lenvatinib 20mg PO QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 19 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment for up to 35 cycles.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Lenvatinib: Given PO\> \> Lenvatinib Mesylate: Given PO\> \> Pembrolizumab: Given IV	Cohort 2 n=27 Participants Previously progressed on Lenvatinib alone\> Patients receive lenvatinib daily dose at progression QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 19 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment for up to 35 cycles.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Lenvatinib: Given PO\> \> Lenvatinib Mesylate: Given PO\> \> Pembrolizumab: Given IV	Total n=57 Participants Total of all reporting groups
Age, Continuous	62.5 years n=5 Participants	60 years n=7 Participants	61 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	7 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	20 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	21 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	27 participants n=7 Participants	57 participants n=5 Participants
Prior systemic VEGFR-active kinase inhibitor therapy Yes	0 Participants n=5 Participants	24 Participants n=7 Participants	24 Participants n=5 Participants
Prior systemic VEGFR-active kinase inhibitor therapy No	30 Participants n=5 Participants	3 Participants n=7 Participants	33 Participants n=5 Participants
Histologic subtype of primary tumor Papillary	19 Participants n=5 Participants	11 Participants n=7 Participants	30 Participants n=5 Participants
Histologic subtype of primary tumor Follicular variant	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Histologic subtype of primary tumor Follicular	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Histologic subtype of primary tumor Hurthle	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Histologic subtype of primary tumor Poorly differentiated	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Histologic subtype of primary tumor Other	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
ECOG Performance Status 0 - Fully active, able to carry on all pre-disease performance without restriction	23 Participants n=5 Participants	11 Participants n=7 Participants	34 Participants n=5 Participants
ECOG Performance Status 1 - Restricted in strenuous activity but ambulatory and able to carry out light or sedentary work	7 Participants n=5 Participants	16 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: 26 months

Population: All evaluable patients in cohort 1 were analyzed for this endpoint.

Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Will use a one-stage binomial design.

Outcome measures

Outcome measures
Measure	Cohort 1 n=29 Participants Lenvatinib-naïve patients\> Patients receive lenvatinib 20mg PO QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 19 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment for up to 35 cycles.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Lenvatinib: Given PO\> \> Lenvatinib Mesylate: Given PO\> \> Pembrolizumab: Given IV	Cohort 2 Previously progressed on Lenvatinib alone\> Patients receive lenvatinib daily dose at progression QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 19 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment for up to 35 cycles.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Lenvatinib: Given PO\> \> Lenvatinib Mesylate: Given PO\> \> Pembrolizumab: Given IV
Complete Response Rate (Cohort 1)	0 percentage of participants	—

PRIMARY outcome

Timeframe: 27 months

Population: All evaluable patients in cohort 2 were analyzed for this endpoint.

Assessed by RECIST 1.1. Will use a 2-stage Simon Optimal MinMax design.

Outcome measures

Outcome measures
Measure	Cohort 1 Lenvatinib-naïve patients\> Patients receive lenvatinib 20mg PO QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 19 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment for up to 35 cycles.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Lenvatinib: Given PO\> \> Lenvatinib Mesylate: Given PO\> \> Pembrolizumab: Given IV	Cohort 2 n=25 Participants Previously progressed on Lenvatinib alone\> Patients receive lenvatinib daily dose at progression QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 19 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment for up to 35 cycles.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Lenvatinib: Given PO\> \> Lenvatinib Mesylate: Given PO\> \> Pembrolizumab: Given IV
Confirmed Response Rate (Cohort 2)	—	16 percentage of participants

SECONDARY outcome

Timeframe: 27 months

Population: All evaluable patients were analyzed for this endpoint.

Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03. All patients that have initiated treatment will be considered evaluable for assessing adverse events. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns. Only the grade 2+ adverse events will be assessed, regardless of relationship to the study treatment.

Outcome measures

Outcome measures
Measure	Cohort 1 n=29 Participants Lenvatinib-naïve patients\> Patients receive lenvatinib 20mg PO QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 19 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment for up to 35 cycles.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Lenvatinib: Given PO\> \> Lenvatinib Mesylate: Given PO\> \> Pembrolizumab: Given IV	Cohort 2 n=25 Participants Previously progressed on Lenvatinib alone\> Patients receive lenvatinib daily dose at progression QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 19 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment for up to 35 cycles.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Lenvatinib: Given PO\> \> Lenvatinib Mesylate: Given PO\> \> Pembrolizumab: Given IV
Number of Patients Experiencing Grade 3+ Adverse Events	26 Participants	14 Participants

SECONDARY outcome

Timeframe: 12 months

Population: All evaluable patients were analyzed for this endpoint.

The distribution of PFS will be estimated using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Cohort 1 n=29 Participants Lenvatinib-naïve patients\> Patients receive lenvatinib 20mg PO QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 19 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment for up to 35 cycles.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Lenvatinib: Given PO\> \> Lenvatinib Mesylate: Given PO\> \> Pembrolizumab: Given IV	Cohort 2 n=25 Participants Previously progressed on Lenvatinib alone\> Patients receive lenvatinib daily dose at progression QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 19 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment for up to 35 cycles.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Lenvatinib: Given PO\> \> Lenvatinib Mesylate: Given PO\> \> Pembrolizumab: Given IV
Progression Free Survival (PFS)	96.6 percentage of patients alive and PF Interval 90.1 to 100.0	48.0 percentage of patients alive and PF Interval 31.9 to 72.2

SECONDARY outcome

Timeframe: 12 months

Population: All evaluable patients were analyzed for this endpoint.

The distribution of survival at 12 months will be estimated using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Cohort 1 n=29 Participants Lenvatinib-naïve patients\> Patients receive lenvatinib 20mg PO QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 19 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment for up to 35 cycles.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Lenvatinib: Given PO\> \> Lenvatinib Mesylate: Given PO\> \> Pembrolizumab: Given IV	Cohort 2 n=25 Participants Previously progressed on Lenvatinib alone\> Patients receive lenvatinib daily dose at progression QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 19 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment for up to 35 cycles.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Lenvatinib: Given PO\> \> Lenvatinib Mesylate: Given PO\> \> Pembrolizumab: Given IV
Overall Survival (OS)	96.6 percentage of patients alive Interval 90.1 to 100.0	76.0 percentage of patients alive Interval 61.0 to 94.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

All analyses with respect to the translational component of this study are intended to be hypothesis-generating and descriptive in manner. Clinical data (i.e. CR rates confirmed response rates, PFS, OS, etc.) will be correlated with tumor marker data of interest (CD8+, PD-L1, PD-L2, T cell functional capacity markers, anti-thyroglobulin antibody levels, tumor mutation status, and other markers). The Chi-Square (or Fisher's Exact test) will be used to assess the association of categorical clinical data with categorical biomarker data. Time-to-event clinical data (PFS, OS) will be correlated with biomarker data using Kaplan-Meier methodology and Cox regression models. Logistic regression models will also be used to predict binary clinical data with baseline biomarker data. Finally, graphical methods and descriptive statistics will be used to summarize the data as well. Two-sided p-values \< 0.05 will be considered statistically significant.

Outcome measures

Outcome data not reported

Adverse Events

Cohort 1

Serious events: 16 serious events

Other events: 30 other events

Deaths: 7 deaths

Cohort 2

Serious events: 8 serious events

Other events: 25 other events

Deaths: 19 deaths

Serious adverse events

Other adverse events

Additional Information

Bryan Haugen, M.D.

University of Colorado, School of Medicine

Phone: 507-266-0800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Cohort 1 n=30 participants at risk Pembrolizumab: Given IV	Cohort 2 n=25 participants at risk Pembrolizumab: Given IV
Cardiac disorders Atrial fibrillation	3.3% 1/30 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events	8.0% 2/25 • Number of events 3 • 27 months All patients that began treatment were assessed for adverse events
Cardiac disorders Myocardial infarction	3.3% 1/30 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Cardiac disorders Myocarditis	0.00% 0/30 • 27 months All patients that began treatment were assessed for adverse events	4.0% 1/25 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events
Gastrointestinal disorders Diarrhea	3.3% 1/30 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Gastrointestinal disorders Dry mouth	3.3% 1/30 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Gastrointestinal disorders Gastric ulcer	3.3% 1/30 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Gastrointestinal disorders Pancreatitis	6.7% 2/30 • Number of events 2 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
General disorders Fatigue	3.3% 1/30 • Number of events 8 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
General disorders Gen disord and admin site conds-Oth spec	0.00% 0/30 • 27 months All patients that began treatment were assessed for adverse events	4.0% 1/25 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events
General disorders Malaise	0.00% 0/30 • 27 months All patients that began treatment were assessed for adverse events	4.0% 1/25 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events
General disorders Pain	3.3% 1/30 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Infections and infestations Enterocolitis infectious	3.3% 1/30 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Infections and infestations Hepatitis viral	3.3% 1/30 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Infections and infestations Infections and infestations - Oth spec	3.3% 1/30 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Infections and infestations Lung infection	3.3% 1/30 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events	4.0% 1/25 • Number of events 2 • 27 months All patients that began treatment were assessed for adverse events
Infections and infestations Sepsis	3.3% 1/30 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Infections and infestations Skin infection	6.7% 2/30 • Number of events 2 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Infections and infestations Urinary tract infection	0.00% 0/30 • 27 months All patients that began treatment were assessed for adverse events	4.0% 1/25 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events
Injury, poisoning and procedural complications Fall	3.3% 1/30 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Injury, poisoning and procedural complications Fracture	0.00% 0/30 • 27 months All patients that began treatment were assessed for adverse events	4.0% 1/25 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events
Injury, poisoning and procedural complications Spinal fracture	3.3% 1/30 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Investigations Alanine aminotransferase increased	3.3% 1/30 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Investigations Alkaline phosphatase increased	3.3% 1/30 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Investigations Aspartate aminotransferase increased	3.3% 1/30 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Investigations Cardiac troponin I increased	0.00% 0/30 • 27 months All patients that began treatment were assessed for adverse events	4.0% 1/25 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events
Investigations Lipase increased	6.7% 2/30 • Number of events 2 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Investigations Serum amylase increased	6.7% 2/30 • Number of events 2 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Investigations Weight loss	3.3% 1/30 • Number of events 2 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Metabolism and nutrition disorders Hypocalcemia	3.3% 1/30 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Metabolism and nutrition disorders Hyponatremia	6.7% 2/30 • Number of events 2 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Musculoskeletal and connective tissue disorders Generalized muscle weakness	3.3% 1/30 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Nervous system disorders Intracranial hemorrhage	3.3% 1/30 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Nervous system disorders Stroke	3.3% 1/30 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Renal and urinary disorders Proteinuria	3.3% 1/30 • Number of events 4 • 27 months All patients that began treatment were assessed for adverse events	4.0% 1/25 • Number of events 4 • 27 months All patients that began treatment were assessed for adverse events
Renal and urinary disorders Renal and urinary disorders - Oth spec	3.3% 1/30 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Reproductive system and breast disorders Vaginal fistula	3.3% 1/30 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Respiratory, thoracic and mediastinal disorders Dyspnea	6.7% 2/30 • Number of events 2 • 27 months All patients that began treatment were assessed for adverse events	8.0% 2/25 • Number of events 2 • 27 months All patients that began treatment were assessed for adverse events
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/30 • 27 months All patients that began treatment were assessed for adverse events	4.0% 1/25 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/30 • 27 months All patients that began treatment were assessed for adverse events	4.0% 1/25 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events
Respiratory, thoracic and mediastinal disorders Resp, thoracic, mediastinal - Oth spec	0.00% 0/30 • 27 months All patients that began treatment were assessed for adverse events	4.0% 1/25 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/30 • 27 months All patients that began treatment were assessed for adverse events	4.0% 1/25 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events
Skin and subcutaneous tissue disorders Rash maculo-papular	3.3% 1/30 • Number of events 1 • 27 months All patients that began treatment were assessed for adverse events	0.00% 0/25 • 27 months All patients that began treatment were assessed for adverse events
Vascular disorders Hypertension	6.7% 2/30 • Number of events 9 • 27 months All patients that began treatment were assessed for adverse events	4.0% 1/25 • Number of events 3 • 27 months All patients that began treatment were assessed for adverse events