Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-426/KEYNOTE-426) (NCT NCT02853331)

Last Updated: 2026-02-02

Results Overview

PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data. The PFS for participants is presented.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

861 participants

Primary outcome timeframe

Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)

Results posted on

2026-02-02

Participant Flow

These interim results are based on a database cutoff date of 24-Aug-2018, at which time 693 participants were ongoing in the study.

Participant milestones

Participant milestones
Measure	Pembrolizumab + Axitinib Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.	Sunitinib Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
Overall Study STARTED	432	429
Overall Study Treated	429	425
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	432	429

Reasons for withdrawal

Reasons for withdrawal
Measure	Pembrolizumab + Axitinib Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.	Sunitinib Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
Overall Study Death	59	95
Overall Study Withdrawal by Subject	5	9
Overall Study Ongoing in study	368	325

Baseline Characteristics

Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-426/KEYNOTE-426)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab + Axitinib n=432 Participants Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.	Sunitinib n=429 Participants Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.	Total n=861 Participants Total of all reporting groups
Age, Continuous	61.2 Years STANDARD_DEVIATION 10.0 • n=13 Participants	60.8 Years STANDARD_DEVIATION 10.2 • n=15 Participants	61.0 Years STANDARD_DEVIATION 10.1 • n=28 Participants
Sex: Female, Male Female	124 Participants n=13 Participants	109 Participants n=15 Participants	233 Participants n=28 Participants
Sex: Female, Male Male	308 Participants n=13 Participants	320 Participants n=15 Participants	628 Participants n=28 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=13 Participants	18 Participants n=15 Participants	37 Participants n=28 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	377 Participants n=13 Participants	387 Participants n=15 Participants	764 Participants n=28 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	36 Participants n=13 Participants	24 Participants n=15 Participants	60 Participants n=28 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants
Race (NIH/OMB) Asian	66 Participants n=13 Participants	71 Participants n=15 Participants	137 Participants n=28 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants
Race (NIH/OMB) Black or African American	10 Participants n=13 Participants	8 Participants n=15 Participants	18 Participants n=28 Participants
Race (NIH/OMB) White	343 Participants n=13 Participants	341 Participants n=15 Participants	684 Participants n=28 Participants
Race (NIH/OMB) More than one race	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=13 Participants	9 Participants n=15 Participants	22 Participants n=28 Participants
International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Risk Group Favorable	138 Participants n=13 Participants	131 Participants n=15 Participants	269 Participants n=28 Participants
International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Risk Group Intermediate	238 Participants n=13 Participants	246 Participants n=15 Participants	484 Participants n=28 Participants
International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Risk Group Poor	56 Participants n=13 Participants	52 Participants n=15 Participants	108 Participants n=28 Participants
Geographic Region North America	104 Participants n=13 Participants	103 Participants n=15 Participants	207 Participants n=28 Participants
Geographic Region Western Europe	106 Participants n=13 Participants	104 Participants n=15 Participants	210 Participants n=28 Participants
Geographic Region Rest of World	222 Participants n=13 Participants	222 Participants n=15 Participants	444 Participants n=28 Participants

PRIMARY outcome

Timeframe: Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)

Population: The analysis population consisted of all randomized participants.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Axitinib n=432 Participants Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.	Sunitinib n=429 Participants Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review	15.1 Months Interval 12.6 to 17.7	11.0 Months Interval 8.7 to 12.5

PRIMARY outcome

Timeframe: Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)

Population: The analysis population consisted of all randomized participants.

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow up. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. The OS for participants is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Axitinib n=432 Participants Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.	Sunitinib n=429 Participants Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
Overall Survival (OS)	NA Months OS median, OS lower limit \& OS upper limit were not reached by the time of the data cutoff (24-Aug-2018).	NA Months OS median, OS lower limit \& OS upper limit were not reached by the time of the data cutoff (24-Aug-2018).

SECONDARY outcome

Timeframe: Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)

Population: The analysis population consisted of all randomized participants.

ORR was determined per RECIST 1.1 and was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The ORR was calculated using the Miettinen \& Nurminen method stratified by International Metastatic Renal Cell Carcinoma (RCC) Database Consortium (IMDC) risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World). The percentage of participants who experienced a CR or PR is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Axitinib n=432 Participants Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.	Sunitinib n=429 Participants Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review	59.3 Percentage of participants Interval 54.5 to 63.9	35.7 Percentage of participants Interval 31.1 to 40.4

SECONDARY outcome

Timeframe: Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)

Population: The analysis population consisted of all randomized participants who experienced a PR, CR or SD for ≥6 months.

DCR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions), Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), or Stable Disease (SD) per RECIST 1.1 for ≥6 months. The DCR was calculated using the Miettinen \& Nurminen method stratified by International Metastatic Renal Cell Carcinoma (RCC) Database Consortium (IMDC) risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World). The percentage of participants who experienced a CR, PR, or SD is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Axitinib n=432 Participants Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.	Sunitinib n=429 Participants Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review	71.5 Percentage of participants Interval 67.0 to 75.7	60.6 Percentage of participants Interval 55.8 to 65.3

SECONDARY outcome

Timeframe: Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)

Population: The analysis population consisted of all randomized participants who experienced a CR or PR.

DOR was defined as the time from first documented evidence of a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 until progressive disease (PD) or death due to any cause, whichever occurred first. PD was defined per RECIST 1.1 as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. The DOR for all participants who experienced a CR or PR is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Axitinib n=256 Participants Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.	Sunitinib n=153 Participants Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review	NA Months Interval 1.4 to Median DOR not reached by the time of the data cutoff (24-Aug-2018). DOR upper limit not calculated due to no progressive disease by the time of last disease assessment.	15.2 Months Interval 1.1 to DOR upper limit not calculated due to no progressive disease by the time of last disease assessment.

SECONDARY outcome

Timeframe: Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)

Population: The analysis population consisted of all participants who received ≥1 dose of study treatment.

An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Axitinib n=429 Participants Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.	Sunitinib n=425 Participants Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
Number of Participants Who Experienced an Adverse Event (AE)	422 Participants	423 Participants

SECONDARY outcome

Timeframe: Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)

Population: The analysis population consisted of all participants who received ≥1 dose of study treatment.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Axitinib n=429 Participants Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.	Sunitinib n=425 Participants Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
Number of Participants Who Discontinued Study Drug Due to an AE	131 Participants	59 Participants

SECONDARY outcome

Timeframe: Month 12

Population: The analysis population consisted of all randomized participants.

The PFS rate was determined in all participants at Month 12. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The date of PD was approximated by the date of the first assessment at which PD was documented per RECIST 1.1 by Blinded Independent Central Review (BICR). Death was always considered as confirmed PD. Participants who did not experience PFS were censored at the last disease assessment. The PFS rate at Month 12 is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Axitinib n=432 Participants Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.	Sunitinib n=429 Participants Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
Progression Free Survival Rate (PFS Rate) at Month 12 in All Participants	59.6 Percentage of participants Interval 54.3 to 64.5	46.1 Percentage of participants Interval 40.5 to 51.5

SECONDARY outcome

Timeframe: Month 18

Population: The analysis population consisted of all randomized participants.

The PFS rate was determined in all participants at Month 18. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The date of PD was approximated by the date of the first assessment at which PD was documented per RECIST 1.1 by Blinded Independent Central Review (BICR). Death was always considered as confirmed PD. Participants who did not experience PFS were censored at the last disease assessment. The PFS rate at Month 18 is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Axitinib n=432 Participants Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.	Sunitinib n=429 Participants Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
Progression Free Survival Rate (PFS Rate) at Month 18 in All Participants	41.1 Percentage of participants Interval 33.5 to 48.5	32.8 Percentage of participants Interval 25.4 to 40.4

SECONDARY outcome

Timeframe: Month 24

The PFS rate was determined in all participants at Month 24. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The date of PD was approximated by the date of the first assessment at which PD was documented per RECIST 1.1 by Blinded Independent Central Review (BICR). Death was always considered as confirmed PD. Participants who did not experience PFS were censored at the last disease assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 12

Population: The analysis population consisted of all randomized participants.

The OS rate was determined for all participants at Month 12 and was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS rate at Month 12 is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Axitinib n=432 Participants Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.	Sunitinib n=429 Participants Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
Overall Survival (OS) Rate at Month 12 in All Participants	89.9 Percentage of participants Interval 86.4 to 92.4	78.3 Percentage of participants Interval 73.8 to 82.1

SECONDARY outcome

Timeframe: Month 18

Population: The analysis population consisted of all randomized participants.

The OS rate was determined for all participants at Month 18 and was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS rate at Month 18 is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Axitinib n=432 Participants Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.	Sunitinib n=429 Participants Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
Overall Survival (OS) Rate at Month 18 in All Participants	82.3 Percentage of participants Interval 77.2 to 86.3	72.1 Percentage of participants Interval 66.3 to 77.0

SECONDARY outcome

Timeframe: Month 24

The OS rate was determined for all participants at Month 24 and was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)

Population: All randomized participants who received at least 1 dose of study medication and completed at least 1 questionnaire assessment.

TTD was defined as time (in months) from the first dose of study treatment to the date of deterioration of FKSI-DRS Score. The FKSI-DRS was a questionnaire that asked the participant to rate 9 kidney cancer-related symptoms: lack of energy, fatigue, weight loss, pain, bone pain, shortness of breath, cough, fever, or blood in the urine. Each item was scored on a 5-point scale (0=not at all to 4=very much). FKSI-DRS total score ranged from 0 (most severe symptoms) to 36 (no symptoms) with a higher score indicating a better outcome. Deterioration was defined as a 3-point decrease (i.e. lower score) in symptom score and the time to true deterioration was the time to first onset of 3 or more decreases from baseline with confirmation under right-censoring rule (the last observation). The time to true deterioration as measured in months is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Axitinib n=395 Participants Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.	Sunitinib n=387 Participants Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
Time to True Deterioration (TTD) of the Functional Assessment of Cancer Therapy Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS) Score	NA Months Interval 12.7 to TTD median not reached by the time of the data cutoff (24-Aug-2018). For TTD upper limit, no deterioration reached by the time of last disease assessment.	NA Months TTD median not reached by the time of the data cutoff (24-Aug-2018). For TTD lower and upper limit, no deterioration reached by the time of last disease assessment.

SECONDARY outcome

Timeframe: Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 54

EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days])

Population: All participants with non-missing questionnaire assessments at baseline.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Axitinib n=394 Participants Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.	Sunitinib n=410 Participants Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
Mean Baseline EORTC Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Score	70.90 Score on a scale Standard Deviation 21.037	72.07 Score on a scale Standard Deviation 20.642

POST_HOC outcome

Timeframe: Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 30

Population: All participants who received at least 1 dose of study medication and had non-missing questionnaire assessments at baseline and Week 30.

EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. The first 28 questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting \[N/V\], constipation, and pain) and a single item (financial difficulties). The last 2 questions represented the participant's assessment of overall health and quality of life on a 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100; with a high score indicating improved health status. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. The LS Mean change from baseline to Week 30 is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Axitinib n=427 Participants Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.	Sunitinib n=423 Participants Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
Least Squares (LS) Mean Change From Baseline to Week 30 in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score	-4.05 Score on a scale Interval -6.03 to -2.07	-2.35 Score on a scale Interval -4.44 to -0.26

Adverse Events

Pembrolizumab + Axitinib

Serious events: 173 serious events

Other events: 417 other events

Deaths: 59 deaths

Sunitinib

Serious events: 133 serious events

Other events: 415 other events

Deaths: 97 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Publication restrictions are in place

Restriction type: OTHER