Trial Outcomes & Findings for A Study to Assess the Clinical Efficacy and Safety of Daratumumab in Participants With Relapsed or Refractory Natural Killer/T-Cell Lymphoma (NKTCL), Nasal Type (NCT NCT02927925)

NCT ID: NCT02927925

Last Updated: 2021-01-14

Results Overview

Overall response was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) per Revised Criteria for Response Assessment of Hodgkin and non-Hodgkin lymphoma: LUGANO classification based on blinded independent central review (BICR). As per Revised Response Criteria for Malignant Lymphoma, Lymph node measurements were taken from Computed Tomography (CT), CT portion of the Positron Emission Tomography/Computed Tomography (PET/CT), where applicable. CR: complete disappearance of all evidence of disease; PR as a greater than (\>) 50 percent (%) decrease in the sum of the products of the maximal perpendicular diameters of measured lesions (SPD) and no new sites.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 32 participants
• Primary outcome timeframe: Up to 2 years and 11 months
• Results posted on: 2021-01-14

Participant Flow

Participant milestones

Measure	Daratumumab Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).
Overall Study STARTED	32
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	32

Reasons for withdrawal

Measure	Daratumumab Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).
Overall Study Death	16
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	11
Overall Study Other	3
Overall Study Disease progression at clinical cutoff	1

Baseline Characteristics

A Study to Assess the Clinical Efficacy and Safety of Daratumumab in Participants With Relapsed or Refractory Natural Killer/T-Cell Lymphoma (NKTCL), Nasal Type

Baseline characteristics by cohort

Measure	Daratumumab n=32 Participants Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).
Age, Continuous	54.8 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	32 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment CHINA	7 Participants n=5 Participants
Region of Enrollment HONG KONG	1 Participants n=5 Participants
Region of Enrollment REPUBLIC OF KOREA	17 Participants n=5 Participants
Region of Enrollment SINGAPORE	2 Participants n=5 Participants
Region of Enrollment TAIWAN, PROVINCE OF CHINA	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years and 11 months

Population: All treated analysis set included all the participants who have received at least one dose of study drug.

Overall response was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) per Revised Criteria for Response Assessment of Hodgkin and non-Hodgkin lymphoma: LUGANO classification based on blinded independent central review (BICR). As per Revised Response Criteria for Malignant Lymphoma, Lymph node measurements were taken from Computed Tomography (CT), CT portion of the Positron Emission Tomography/Computed Tomography (PET/CT), where applicable. CR: complete disappearance of all evidence of disease; PR as a greater than (>) 50 percent (%) decrease in the sum of the products of the maximal perpendicular diameters of measured lesions (SPD) and no new sites.

Outcome measures

Measure	Daratumumab n=32 Participants Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).
Percentage of Participants With Overall Response	25.0 percentage of participants Interval 11.5 to 43.4

SECONDARY outcome

Timeframe: Up to 2 years and 11 months

Population: All treated analysis set included all the participants who have received at least one dose of study drug.

CR was defined as the percentage of participants who achieved CR as per Revised Criteria for Response Assessment of Hodgkin and non-Hodgkin lymphoma: LUGANO classification based on BICR. CR was a complete disappearance of all evidence of disease.

Outcome measures

Measure	Daratumumab n=32 Participants Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).
Percentage of Participants With Complete Response (CR)	3.1 percentage of participants Interval 0.08 to 16.22

SECONDARY outcome

Timeframe: Up to 2 years and 11 months

Population: All treated analysis set included all the participants who have received at least one dose of study drug.

PFS was defined as the duration from the date of the first daratumumab dose to the date of progression/relapse or death, whichever came first. Progressive disease (PD) was defined as any new lesion greater than (>) 1.5 centimeter (cm) in any axis or greater than or equal to (>=) 50 percent (%) increase in previously involved sites.

Outcome measures

Measure	Daratumumab n=32 Participants Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).
Progression Free Survival (PFS)	53.0 days Interval 43.0 to 106.0

SECONDARY outcome

Timeframe: Up to 2 years and 11 months

Population: All treated analysis set included all the participants who have received at least one dose of study drug and had CR or PR.

DoR was defined as duration from the date of the initial documentation of a response to the date of first documented evidence of progressive disease (PD) (or relapse for participants who experienced CR). PD was defined as any new lesion >1.5 cm in any axis or >= 50% increase in previously involved sites.

Outcome measures

Measure	Daratumumab n=8 Participants Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).
Duration of Response (DoR)	55.0 days Interval 29.0 to 339.0

SECONDARY outcome

Timeframe: Up to 2 years and 11 months

Population: All treated analysis set included all the participants who have received at least one dose of study drug and had CR or PR.

Time to response was defined as the duration from the date of the first dose of daratumumab to the earliest date that a response (CR/PR based on BICR) is first documented. CR was defined as complete disappearance of all evidence of disease; PR as a greater than (>) 50 percent (%) decrease in the sum of the products of the maximal perpendicular diameters of measured lesions (SPD) and no new sites.

Outcome measures

Measure	Daratumumab n=8 Participants Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).
Time to Response	52.0 days Interval 49.0 to 57.0

SECONDARY outcome

Timeframe: Up to 2 years and 11 months

Population: All treated analysis set included all the participants who have received at least one dose of study drug.

OS was defined as the duration from the date of the first daratumumab dose to the date of death.

Outcome measures

Measure	Daratumumab n=32 Participants Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).
Overall Survival (OS)	141.0 days Interval 94.0 to 235.0

SECONDARY outcome

Timeframe: Up to 2 years and 11 months

Population: All treated analysis set included all the participants who have received at least one dose of study drug.

An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAE were defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline.

Outcome measures

Measure	Daratumumab n=32 Participants Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).
Number of Participants With Treatment Emergent Adverse Events (TEAE) as a Measure of Safety and Tolerability	26 Participants

SECONDARY outcome

Timeframe: Up to 2 years and 11 months

Population: All treated analysis set included all the participants who have received at least one dose of study drug.

Number of participants with clinically significant change in vital signs (blood pressure, temperature, pulse rate, and weight) was reported.

Outcome measures

Measure	Daratumumab n=32 Participants Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).
Number of Participants With Clinically Significant Change in Vital Signs	0 Participants

SECONDARY outcome

Timeframe: Up to 2 years and 11 months

Population: All treated analysis set included all the participants who have received at least one dose of study drug.

Number of participants with clinically significant ECG abnormalities were reported.

Outcome measures

Measure	Daratumumab n=32 Participants Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities	2 Participants

SECONDARY outcome

Timeframe: Up to 2 years and 11 months

Population: All treated analysis set included all the participants who have received at least one dose of study drug.

Number of participants with clinically significant change in physical finding was reported.

Outcome measures

Measure	Daratumumab n=32 Participants Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).
Number of Participants With Clinically Significant Change in Physical Finding	0 Participants

SECONDARY outcome

Timeframe: Up to 2 years and 11 months

Population: All treated analysis set included all the participants who have received at least one dose of study drug.

Number of participants with clinically significant change in hematology (WBC, hemoglobin, platelets, neutrophils, and lymphocytes) and biochemistry (alanine transaminase [ALT], aspartate transaminase [AST], sodium, potassium, bilirubin, alkaline phosphatase, calcium laboratory parameters were reported.

Outcome measures

Measure	Daratumumab n=32 Participants Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).
Number of Participants With Clinically Significant Change in Laboratory Parameters Chemistry: AST	0 Participants
Number of Participants With Clinically Significant Change in Laboratory Parameters Chemistry: Alkaline phosphatase	0 Participants
Number of Participants With Clinically Significant Change in Laboratory Parameters Hematology: WBC	0 Participants
Number of Participants With Clinically Significant Change in Laboratory Parameters Hematology: Hemoglobin	0 Participants
Number of Participants With Clinically Significant Change in Laboratory Parameters Hematology: Platelets	0 Participants
Number of Participants With Clinically Significant Change in Laboratory Parameters Hematology: Neutrophils	0 Participants
Number of Participants With Clinically Significant Change in Laboratory Parameters Hematology: Lymphocytes	0 Participants
Number of Participants With Clinically Significant Change in Laboratory Parameters Chemistry: ALT	0 Participants
Number of Participants With Clinically Significant Change in Laboratory Parameters Chemistry: Sodium	0 Participants
Number of Participants With Clinically Significant Change in Laboratory Parameters Chemistry: Potassium	0 Participants
Number of Participants With Clinically Significant Change in Laboratory Parameters Chemistry: Bilirubin	0 Participants
Number of Participants With Clinically Significant Change in Laboratory Parameters Chemistry: Calcium	0 Participants

Adverse Events

Daratumumab

Serious events: 17 serious events

Other events: 31 other events

Deaths: 21 deaths

Serious adverse events

Measure	Daratumumab n=32 participants at risk Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).
Blood and lymphatic system disorders Febrile Neutropenia	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Blood and lymphatic system disorders Neutropenia	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	9.4% 3/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Eye disorders Periorbital Swelling	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Eye disorders Uveitis	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
General disorders Death	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
General disorders Pyrexia	15.6% 5/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Hepatobiliary disorders Hyperbilirubinaemia	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Infections and infestations Cellulitis	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Infections and infestations Epstein-Barr Virus Infection	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Infections and infestations Hepatitis Infectious Mononucleosis	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Infections and infestations Oral Candidiasis	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Infections and infestations Pneumonia	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Infections and infestations Septic Shock	9.4% 3/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Infections and infestations Skin Infection	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Nervous system disorders Headache	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.

Other adverse events

Measure	Daratumumab n=32 participants at risk Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).
Blood and lymphatic system disorders Anaemia	28.1% 9/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Blood and lymphatic system disorders Leukocytosis	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Blood and lymphatic system disorders Leukopenia	21.9% 7/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Blood and lymphatic system disorders Lymphopenia	9.4% 3/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Blood and lymphatic system disorders Neutropenia	21.9% 7/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	28.1% 9/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Cardiac disorders Angina Pectoris	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Cardiac disorders Atrial Fibrillation	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Cardiac disorders Myocarditis	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Cardiac disorders Pericardial Effusion	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Cardiac disorders Supraventricular Tachycardia	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Cardiac disorders Tachycardia	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Ear and labyrinth disorders Ear Discomfort	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Ear and labyrinth disorders Tinnitus	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Ear and labyrinth disorders Vertigo	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Endocrine disorders Steroid Withdrawal Syndrome	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Eye disorders Cataract	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Eye disorders Diplopia	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Eye disorders Eye Swelling	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Eye disorders Periorbital Oedema	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Eye disorders Periorbital Swelling	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Eye disorders Uveitis	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Eye disorders Vision Blurred	9.4% 3/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Eye disorders Vitritis	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Gastrointestinal disorders Abdominal Discomfort	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Gastrointestinal disorders Abdominal Distension	12.5% 4/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Gastrointestinal disorders Abdominal Pain	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Gastrointestinal disorders Abdominal Pain Upper	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Gastrointestinal disorders Anorectal Swelling	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Gastrointestinal disorders Aphthous Ulcer	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Gastrointestinal disorders Constipation	12.5% 4/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Gastrointestinal disorders Dyspepsia	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Gastrointestinal disorders Enterocolitis	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Gastrointestinal disorders Gingival Pain	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Gastrointestinal disorders Haemorrhoids	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Gastrointestinal disorders Mouth Ulceration	9.4% 3/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Gastrointestinal disorders Nausea	15.6% 5/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Gastrointestinal disorders Proctalgia	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Gastrointestinal disorders Stomatitis	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Gastrointestinal disorders Vomiting	12.5% 4/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
General disorders Asthenia	9.4% 3/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
General disorders Chest Discomfort	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
General disorders Chills	25.0% 8/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
General disorders Face Oedema	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
General disorders Fatigue	21.9% 7/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
General disorders Generalised Oedema	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
General disorders Influenza Like Illness	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
General disorders Oedema	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
General disorders Oedema Peripheral	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
General disorders Pain	12.5% 4/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
General disorders Pyrexia	62.5% 20/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
General disorders Swelling Face	9.4% 3/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Hepatobiliary disorders Hyperbilirubinaemia	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Immune system disorders Immunodeficiency	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Infections and infestations Eye Infection	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Infections and infestations Gingivitis	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Infections and infestations Herpes Zoster	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Infections and infestations Influenza	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Infections and infestations Localised Infection	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Infections and infestations Nasopharyngitis	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Infections and infestations Oral Candidiasis	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Infections and infestations Oropharyngeal Candidiasis	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Infections and infestations Otitis Media	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Infections and infestations Pharyngitis	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Infections and infestations Pneumonia	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Infections and infestations Sinusitis	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Infections and infestations Skin Infection	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Infections and infestations Upper Respiratory Tract Infection	9.4% 3/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Infections and infestations Urinary Tract Infection	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Injury, poisoning and procedural complications Limb Injury	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Investigations Activated Partial Thromboplastin Time Prolonged	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Investigations Alanine Aminotransferase Increased	28.1% 9/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Investigations Aspartate Aminotransferase Increased	25.0% 8/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Investigations Blood Alkaline Phosphatase Increased	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Investigations Blood Chloride Decreased	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Investigations Blood Creatinine Increased	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Investigations Blood Lactate Dehydrogenase Increased	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Investigations C-Reactive Protein Increased	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Investigations Gamma-Glutamyltransferase Increased	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Investigations Influenza B Virus Test Positive	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Investigations Interleukin Level Increased	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Metabolism and nutrition disorders Decreased Appetite	9.4% 3/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Metabolism and nutrition disorders Diabetes Mellitus	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Metabolism and nutrition disorders Dyslipidaemia	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Metabolism and nutrition disorders Electrolyte Imbalance	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Metabolism and nutrition disorders Hypocalcaemia	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Metabolism and nutrition disorders Hypochloraemia	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Metabolism and nutrition disorders Hypoglycaemia	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Metabolism and nutrition disorders Hypomagnesaemia	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	18.8% 6/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Metabolism and nutrition disorders Hypophosphataemia	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Metabolism and nutrition disorders Hypoproteinaemia	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Metabolism and nutrition disorders Malnutrition	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back Pain	12.5% 4/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscle Spasms	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal Stiffness	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	12.5% 4/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Neck Pain	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in Extremity	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer Pain	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraneoplastic Syndrome	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Pain	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Nervous system disorders Convulsions Local	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Nervous system disorders Dizziness	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Nervous system disorders Headache	25.0% 8/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Nervous system disorders Hypoaesthesia	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Nervous system disorders Limbic Encephalitis	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Nervous system disorders Lumbosacral Radiculopathy	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Nervous system disorders Paraesthesia	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Nervous system disorders Tremor	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Psychiatric disorders Delirium	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Psychiatric disorders Hallucination	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Psychiatric disorders Insomnia	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Renal and urinary disorders Haemoglobinuria	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Renal and urinary disorders Polyuria	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Renal and urinary disorders Proteinuria	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Renal and urinary disorders Urinary Incontinence	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 4/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dry Throat	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Hiccups	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal Obstruction	9.4% 3/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	6.2% 2/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Skin and subcutaneous tissue disorders Erythema	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Skin and subcutaneous tissue disorders Night Sweats	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	12.5% 4/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	21.9% 7/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin Haemorrhage	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin Lesion	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Skin and subcutaneous tissue disorders Urticaria	9.4% 3/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Vascular disorders Hypertension	3.1% 1/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.
Vascular disorders Hypotension	15.6% 5/32 • Up to 2 years and 11 months All treated analysis set included all the participants who have received at least one dose of study drug.

Additional Information

Global Medical Head

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
• Publication restrictions are in place

Restriction type: OTHER