Trial Outcomes & Findings for Open-Label Study Evaluating Dasatinib Therapy Discontinuation in Patients With Chronic Phase Chronic Myeloid Leukemia With Stable Complete Molecular Response (NCT NCT01850004)

Last Updated: 2022-11-03

Results Overview

Major Molecular Response (MMR) rate at 12 months is the percentage of participants who maintain MMR (BCR-ABL transcripts \< 0.1% on the International Scale \[IS\]) at 12 months after Dasatinib discontinuation without restarting Dasatinib

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

84 participants

Primary outcome timeframe

At 12 months after Dasatinib discontinuation (assessed up to approximately June 4, 2018)

Results posted on

2022-11-03

Participant Flow

Participant milestones

Participant milestones
Measure	Total Prior to study entry participants received dasatinib as treatment for a minimum of 2 years. Upon enrollment dasatinib will be discontinued. Dasatinib will be restarted if major molecular response is lost during the off-treatment period at the dose level received before study entry. The participant will remain on treatment for the duration of the study.
Overall Study STARTED	84
Overall Study Restart Treatment	47
Overall Study Discontinued Study Treatment After Restart	47
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Total Prior to study entry participants received dasatinib as treatment for a minimum of 2 years. Upon enrollment dasatinib will be discontinued. Dasatinib will be restarted if major molecular response is lost during the off-treatment period at the dose level received before study entry. The participant will remain on treatment for the duration of the study.
Overall Study Poor/Non-compliance	1
Overall Study Participant Withdrew Consent	9
Overall Study Participant Request to Discontinue Treatment	2
Overall Study Adverse Event Unrelated to Study Drug	1
Overall Study Adverse Event Related to Study Drug	4
Overall Study Other Reasons	2
Overall Study Participant No Longer Meets Study Criteria	1
Overall Study Maximum Clinical Benefit	4

Baseline Characteristics

Open-Label Study Evaluating Dasatinib Therapy Discontinuation in Patients With Chronic Phase Chronic Myeloid Leukemia With Stable Complete Molecular Response

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total n=84 Participants Prior to study entry participants received dasatinib as treatment for a minimum of 2 years. Upon enrollment dasatinib will be discontinued. Dasatinib will be restarted if major molecular response is lost during the off-treatment period at the dose level received before study entry. The participant will remain on treatment for the duration of the study.
Age, Continuous	52.6 Years STANDARD_DEVIATION 14.57 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants
Race/Ethnicity, Customized White	75 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 12 months after Dasatinib discontinuation (assessed up to approximately June 4, 2018)

Population: All enrolled participants

Outcome measures

Outcome measures
Measure	Total n=84 Participants Prior to study entry participants received dasatinib as treatment for a minimum of 2 years. Upon enrollment dasatinib will be discontinued. Dasatinib will be restarted if major molecular response is lost during the off-treatment period at the dose level received before study entry. The participant will remain on treatment for the duration of the study.
Major Molecular Response (MMR) Rate	47.6 Percentage of Participants Interval 36.6 to 58.8

SECONDARY outcome

Timeframe: From 12 months after Dasatinib treatment discontinuation to every 12 months thereafter (up to approximately 60 months)

Population: All enrolled participants

Event-free survival (EFS) rate is defined as the percentage of surviving participants with no loss of Major Molecular Response (MMR) at the specified timepoints after dasatinib discontinuation. MMR is defined as BCR-ABL transcripts \< 0.1% IS. Loss of MMR is defined per the European LeukemiaNet (ELN) definition of progression. Progression is defined as Transformation to Accelerated Phase or Blast Crisis (AP/BC): Accelerated Phase (AP) Blasts in PB or BM 15-29%; Blast + promyelocytes ≥ 30% with blasts \< 30% or ACA in Ph+ cells (clonal progression), or basophils in blood ≥ 20%,or platelets \< 100 x 10\^9 /L unrelated to therapy Blastic Phase or Crisis (BP/BC) Blasts in PB or BM ≥ 30%, or extramedullary blast cell involvement (with exception of spleen and liver) The date of progression is defined as the date any of the above criteria is first met. Participants who have not progressed will be censored on the date of last examination.

Outcome measures

Outcome measures
Measure	Total n=84 Participants Prior to study entry participants received dasatinib as treatment for a minimum of 2 years. Upon enrollment dasatinib will be discontinued. Dasatinib will be restarted if major molecular response is lost during the off-treatment period at the dose level received before study entry. The participant will remain on treatment for the duration of the study.
Event-Free Survival (EFS) Rate At 12 months	48.7 Percentage of participants Interval 38.0 to 59.4
Event-Free Survival (EFS) Rate At 24 months	46.3 Percentage of participants Interval 35.6 to 57.0
Event-Free Survival (EFS) Rate At 36 months	45.0 Percentage of participants Interval 34.3 to 55.7
Event-Free Survival (EFS) Rate At 48 months	43.8 Percentage of participants Interval 33.1 to 54.4
Event-Free Survival (EFS) Rate At 60 months	43.8 Percentage of participants Interval 33.1 to 54.4

SECONDARY outcome

Timeframe: From 12 months after Dasatinib treatment discontinuation to every 6 months thereafter (up to approximately 60 months)

Population: All enrolled participants

RFS is the percentage of participants who did not relapse at the specified timepoints. Participants who did not relapse were censored on the date of their last molecular assessment. Relapse is defined as any of the following events while on study: the loss of Major Molecular Response (MMR), loss of Complete Cytogenetic Response (CCyR), loss of Complete Hematologic Response (CHR) or progression to advanced/blastic phase. MMR is defined as BCR-ABL transcripts \< 0.1% IS. Cytogenetic response (CyR) is based on the prevalence of Ph+ cells in metaphase from bone marrow (BM) sample based on evaluation of at least 20 metaphases. CCyR is defined as 0% Ph+ cells in metaphase in BM. CHR is obtained when all the following criteria are met in peripheral blood (PB) sampling: white blood cell ≤10,000/mm3; Platelets \< 450,000/mm3; PB basophils \<5%; No blasts or promyelocytes in PB; \<5% myelocytes plus metamyelocytes in PB; No extramedullary involvement (including no hepatomegaly or splenomegaly).

Outcome measures

Outcome measures
Measure	Total n=84 Participants Prior to study entry participants received dasatinib as treatment for a minimum of 2 years. Upon enrollment dasatinib will be discontinued. Dasatinib will be restarted if major molecular response is lost during the off-treatment period at the dose level received before study entry. The participant will remain on treatment for the duration of the study.
Relapse-Free Survival (RFS) Rate At 6 Months	61.9 Percentage of Participants Interval 51.5 to 72.3
Relapse-Free Survival (RFS) Rate At 12 Months	48.7 Percentage of Participants Interval 38.0 to 59.4
Relapse-Free Survival (RFS) Rate At 18 Months	47.5 Percentage of Participants Interval 36.8 to 58.2
Relapse-Free Survival (RFS) Rate At 24 months	46.3 Percentage of Participants Interval 35.6 to 57.0
Relapse-Free Survival (RFS) Rate At 30 months	46.3 Percentage of Participants Interval 35.6 to 57.0
Relapse-Free Survival (RFS) Rate At 36 months	45.0 Percentage of Participants Interval 34.4 to 55.7
Relapse-Free Survival (RFS) Rate At 42 months	43.8 Percentage of Participants Interval 33.1 to 54.4
Relapse-Free Survival (RFS) Rate At 48 months	43.8 Percentage of Participants Interval 33.1 to 54.4
Relapse-Free Survival (RFS) Rate At 54 months	43.8 Percentage of Participants Interval 33.1 to 54.4
Relapse-Free Survival (RFS) Rate At 60 months	43.8 Percentage of Participants Interval 33.1 to 54.4

SECONDARY outcome

Timeframe: From 12 months after Dasatinib treatment discontinuation to every 6 months thereafter (up to approximately 60 months)

Population: All enrolled participants

Progression free survival (PFS) is defined as the percentage of participants who experienced death (due to any cause) or accelerated phase, or blast crisis. Participants who neither progress nor die will be censored on the date of their last molecular assessment. Progression is defined as Transformation to Accelerated Phase or Blast Crisis (AP/BC) Accelerated Phase (AP) Blasts in PB or BM 15-29%; Blast + promyelocytes \>= 30% with blasts \< 30% or ACA in Ph+ cells (clonal progression), or basophils in blood \>= 20%,or platelets \< 100 x 109 /L unrelated to therapy Blastic Phase or Crisis (BP/BC) Blasts in PB or BM \>= 30%, or extramedullary blast cell involvement (with the exception of spleen and liver)

Outcome measures

Outcome measures
Measure	Total n=84 Participants Prior to study entry participants received dasatinib as treatment for a minimum of 2 years. Upon enrollment dasatinib will be discontinued. Dasatinib will be restarted if major molecular response is lost during the off-treatment period at the dose level received before study entry. The participant will remain on treatment for the duration of the study.
Progression Free Survival (PFS) Rate At 6 months	100.0 Percentage of participants Interval 100.0 to 100.0
Progression Free Survival (PFS) Rate At 12 months	100.0 Percentage of participants Interval 100.0 to 100.0
Progression Free Survival (PFS) Rate At 18 months	100.0 Percentage of participants Interval 100.0 to 100.0
Progression Free Survival (PFS) Rate At 24 months	98.7 Percentage of participants Interval 96.2 to 100.0
Progression Free Survival (PFS) Rate At 30 months	98.7 Percentage of participants Interval 96.2 to 100.0
Progression Free Survival (PFS) Rate At 36 months	98.7 Percentage of participants Interval 96.2 to 100.0
Progression Free Survival (PFS) Rate At 42 months	98.7 Percentage of participants Interval 96.2 to 100.0
Progression Free Survival (PFS) Rate At 48 months	98.7 Percentage of participants Interval 96.2 to 100.0
Progression Free Survival (PFS) Rate At 54 months	98.7 Percentage of participants Interval 96.2 to 100.0
Progression Free Survival (PFS) Rate At 60 months	98.7 Percentage of participants Interval 96.2 to 100.0

SECONDARY outcome

Timeframe: 60 months after last dose

Population: Participants with no loss of major molecular response (MMR)

The number of participants who did not lose major molecular response (MMR) 60 months after discontinuing study treatment who were in MR4.5 at the time of discontinuation and lost MR4.5. Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (Q-PCR). MMR is defined as BCR-ABL transcripts \< 0.1% Internal Standard (IS). CMR (MR4.5) defined as ≤ 0.0032% (IS) or ≥ 4.5 log reduction of BCR-ABL transcript levels molecular response.

Outcome measures

Outcome measures
Measure	Total n=31 Participants Prior to study entry participants received dasatinib as treatment for a minimum of 2 years. Upon enrollment dasatinib will be discontinued. Dasatinib will be restarted if major molecular response is lost during the off-treatment period at the dose level received before study entry. The participant will remain on treatment for the duration of the study.
Number of Participants Who Experience Intermittent Loss of Complete Molecular Response (CMR) (MR4.5) But no Loss of Major Molecular Response (MMR)	19 Participants

SECONDARY outcome

Timeframe: From 12 months after Dasatinib treatment discontinuation to 5 years after the first visit of the last enrolled participant (up to approximately 82 months)

Population: All enrolled participants

Assessment of BCR-ABL kinetics in patients who are in CMR (MR4.5) or less when transcript levels are still measurable. CMR (MR4.5) defined as ≤ 0.0032% (IS) or ≥ 4.5 log reduction of BCR-ABL transcript levels molecular response.

Outcome measures

Outcome measures
Measure	Total n=31 Participants Prior to study entry participants received dasatinib as treatment for a minimum of 2 years. Upon enrollment dasatinib will be discontinued. Dasatinib will be restarted if major molecular response is lost during the off-treatment period at the dose level received before study entry. The participant will remain on treatment for the duration of the study.
Number of Participants Who Did Not Experience Loss of Complete Molecular Response (CMR) (MR4.5) and Major Molecular Response (MMR)	12 Participants

SECONDARY outcome

Timeframe: From 12 months after Dasatinib treatment discontinuation to 5 years after the first visit of the last enrolled participant (up to approximately 82 months)

Population: All enrolled participants

Time to Transformation to AP/BC is defined as the rate at which participants experienced transformation to accelerated phase/blast crisis (AP/BC) since discontinuation. Participants who did not develop to AP, late phase, or BC phase were censored on their last molecular measurement date.

Outcome measures

Outcome measures
Measure	Total n=84 Participants Prior to study entry participants received dasatinib as treatment for a minimum of 2 years. Upon enrollment dasatinib will be discontinued. Dasatinib will be restarted if major molecular response is lost during the off-treatment period at the dose level received before study entry. The participant will remain on treatment for the duration of the study.
Time to Transformation to Accelerated Phase/Blast Crisis (AP/BC)	NA Months The median, lower and upper limits were incalculable due to insufficient number of events

SECONDARY outcome

Timeframe: From 12 months after Dasatinib treatment discontinuation to the date of death or last known alive date (up to approximately 82 months)

Population: All enrolled participants

Overall survival (OS) is defined as the time from dasatinib treatment discontinuation to the date of death (due to any cause) or last known alive date. Participants who do not die will be censored on their last known alive date.

Outcome measures

Outcome measures
Measure	Total n=84 Participants Prior to study entry participants received dasatinib as treatment for a minimum of 2 years. Upon enrollment dasatinib will be discontinued. Dasatinib will be restarted if major molecular response is lost during the off-treatment period at the dose level received before study entry. The participant will remain on treatment for the duration of the study.
Overall Survival (OS)	NA Months Median, lower limit, and upper limit not calculated due to insufficient number of events.

SECONDARY outcome

Timeframe: From treatment discontinuation to the date of progression or death due to any cause, whichever occurs first (up to 82 months)

Population: All enrolled participants

Progression-free survival (PFS) is defined as the time from treatment discontinuation to the date of progression or death (due to any cause), whichever occurs first. Participants who neither progress nor die will be censored on the date of their last molecular assessment.

Outcome measures

Outcome measures
Measure	Total n=84 Participants Prior to study entry participants received dasatinib as treatment for a minimum of 2 years. Upon enrollment dasatinib will be discontinued. Dasatinib will be restarted if major molecular response is lost during the off-treatment period at the dose level received before study entry. The participant will remain on treatment for the duration of the study.
Progression Free Survival	NA Months Median, lower and upper limit not calculated due to insufficient number of events.

Adverse Events

Total

Serious events: 8 serious events

Other events: 42 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Total n=47 participants at risk Prior to study entry participants received dasatinib as treatment for a minimum of 2 years. Upon enrollment dasatinib will be discontinued. Dasatinib will be restarted if major molecular response is lost during the off-treatment period at the dose level received before study entry. The participant will remain on treatment for the duration of the study.
Blood and lymphatic system disorders Lymphadenopathy	2.1% 1/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Cardiac disorders Myocardial ischaemia	2.1% 1/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Cardiac disorders Pericarditis	2.1% 1/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Ear and labyrinth disorders Deafness	2.1% 1/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Gastrointestinal disorders Abdominal pain	2.1% 1/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Infections and infestations External ear cellulitis	2.1% 1/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Musculoskeletal and connective tissue disorders Polychondritis	2.1% 1/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	2.1% 1/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer metastatic	2.1% 1/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	2.1% 1/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Nervous system disorders Syncope	2.1% 1/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.

Other adverse events

Other adverse events
Measure	Total n=47 participants at risk Prior to study entry participants received dasatinib as treatment for a minimum of 2 years. Upon enrollment dasatinib will be discontinued. Dasatinib will be restarted if major molecular response is lost during the off-treatment period at the dose level received before study entry. The participant will remain on treatment for the duration of the study.
Blood and lymphatic system disorders Neutropenia	6.4% 3/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Gastrointestinal disorders Constipation	12.8% 6/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Gastrointestinal disorders Diarrhoea	8.5% 4/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Gastrointestinal disorders Dry mouth	6.4% 3/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Gastrointestinal disorders Haemorrhoids	8.5% 4/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Gastrointestinal disorders Vomiting	6.4% 3/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
General disorders Asthenia	10.6% 5/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
General disorders Fatigue	21.3% 10/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
General disorders Oedema peripheral	6.4% 3/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
General disorders Pyrexia	8.5% 4/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Infections and infestations Nasopharyngitis	14.9% 7/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Infections and infestations Sinusitis	8.5% 4/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Infections and infestations Upper respiratory tract infection	8.5% 4/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Infections and infestations Viral infection	6.4% 3/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Metabolism and nutrition disorders Hypercholesterolaemia	6.4% 3/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Musculoskeletal and connective tissue disorders Arthralgia	14.9% 7/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Musculoskeletal and connective tissue disorders Back pain	8.5% 4/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Musculoskeletal and connective tissue disorders Myalgia	12.8% 6/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	6.4% 3/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Nervous system disorders Dizziness	6.4% 3/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Nervous system disorders Headache	12.8% 6/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Psychiatric disorders Depression	6.4% 3/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Psychiatric disorders Insomnia	6.4% 3/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Respiratory, thoracic and mediastinal disorders Cough	8.5% 4/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.4% 3/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	8.5% 4/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Skin and subcutaneous tissue disorders Rash	10.6% 5/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
Vascular disorders Hypertension	8.5% 4/47 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months) The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER