Trial Outcomes & Findings for Efficacy and Safety of Zanubrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (NCT NCT03206918)

NCT ID: NCT03206918

Last Updated: 2024-10-26

Results Overview

ORR is defined as the number of participants who achieve a best response of CR or, CRi, Nodular Partial Response, PR, and PR with Lymphocytosis as assessed by IRC per the modified IWCLL Guidelines in participants with CLL and the Revised Criteria for Response for Malignant Lymphoma in participants with SLL.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

91 participants

Primary outcome timeframe

Up to 1 year and 4 months

Results posted on

2024-10-26

Participant Flow

91 participants were enrolled at 11 sites in China. The first participant was dosed on 09 March 2017. Database lock date for the primary outcome measure was 14 December 2018. Final database lock date was 16 October 2020.

Participant milestones

Participant milestones
Measure	Zanubrutinib 160 mg administered orally (two - 80 mg white opaque capsules) twice a day (BID) for up to three years or until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by the sponsor.
Overall Study STARTED	91
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	91

Reasons for withdrawal

Reasons for withdrawal
Measure	Zanubrutinib 160 mg administered orally (two - 80 mg white opaque capsules) twice a day (BID) for up to three years or until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by the sponsor.
Overall Study Death	11
Overall Study Withdrawal by Subject	5
Overall Study Study terminated by sponsor	12
Overall Study Lost to Follow-up	3
Overall Study Transferred to extension study BGB-3111-LTE1 (NCT04170283)	60

Baseline Characteristics

Efficacy and Safety of Zanubrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zanubrutinib n=91 Participants 160 mg administered orally (two - 80 mg white opaque capsules) twice a day (BID) for up to three years or until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by the sponsor.
Age, Continuous	60.9 years STANDARD_DEVIATION 9.73 • n=99 Participants
Age, Customized <65	60 Participants n=99 Participants
Age, Customized ≥65	31 Participants n=99 Participants
Sex: Female, Male Female	39 Participants n=99 Participants
Sex: Female, Male Male	52 Participants n=99 Participants
Race/Ethnicity, Customized Chinese	91 participants n=99 Participants
Race/Ethnicity, Customized Other	0 participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 1 year and 4 months

Population: Modified Safety Analysis Set: All participants in the safety analysis set who had confirmed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Outcome measures

Outcome measures
Measure	Zanubrutinib n=91 Participants 160 mg administered orally (two - 80 mg white opaque capsules) twice a day (BID) for up to 3.5 years or until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by the sponsor.
Overall Response Rate (ORR) by Independent Review Committee (IRC)	80 Participants

SECONDARY outcome

Timeframe: 6, 12, 24, and 36 months

Population: The Safety Analysis Set included all participants who received ≥ 1 doses of study drug. All efficacy analyses were based on the Safety Analysis Set

PFS is defined as the time from treatment initiation to first documentation of progression by International workshop on chronic lymphocytic leukemia (IWCLL) criteria/revised criteria for response for malignant lymphoma or death, whichever is earlier.

Outcome measures

Outcome measures
Measure	Zanubrutinib n=91 Participants 160 mg administered orally (two - 80 mg white opaque capsules) twice a day (BID) for up to 3.5 years or until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by the sponsor.
Progression-free Survival (PFS): Percentage of Participants Progression/Death Event Free 6 months	93.3 Percentage of participants Interval 85.72 to 96.94
Progression-free Survival (PFS): Percentage of Participants Progression/Death Event Free 12 months	88.7 Percentage of participants Interval 80.04 to 93.77
Progression-free Survival (PFS): Percentage of Participants Progression/Death Event Free 24 months	80.5 Percentage of participants Interval 70.52 to 87.42
Progression-free Survival (PFS): Percentage of Participants Progression/Death Event Free 36 months	68.1 Percentage of participants Interval 56.56 to 77.24

SECONDARY outcome

Timeframe: 6, 12, 24, and 36 months

Population: The Safety Analysis Set included all participants who received ≥ 1 doses of study drug. Duration of response was summarized for responders (with Best Overall Response of partial response with lymphocytosis (PR-L) or above) only

DOR is defined as the time from the date that response criteria are first met to the date that progressive disease (PD) is objectively documented or death, whichever occurs first

Outcome measures

Outcome measures
Measure	Zanubrutinib n=80 Participants 160 mg administered orally (two - 80 mg white opaque capsules) twice a day (BID) for up to 3.5 years or until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by the sponsor.
Duration of Response (DOR): Event Free Rate - Percentage of Participants Who Remained Event Free 6 Months	97.5 Percentage of participants Interval 90.37 to 99.37
Duration of Response (DOR): Event Free Rate - Percentage of Participants Who Remained Event Free 12 Months	92.5 Percentage of participants Interval 83.96 to 96.54
Duration of Response (DOR): Event Free Rate - Percentage of Participants Who Remained Event Free 24 Months	83.4 Percentage of participants Interval 73.2 to 90.04
Duration of Response (DOR): Event Free Rate - Percentage of Participants Who Remained Event Free 36 Months	69.9 Percentage of participants Interval 57.02 to 79.55

SECONDARY outcome

Timeframe: Up to 3.5 years

Population: The Safety Analysis Set included all participants who received ≥ 1 doses of study drug. Time to response was summarized for responders (those who achieved a best overall response of at least PR-L) only

TTR is defined as the time from treatment initiation to first signs of response

Outcome measures

Outcome measures
Measure	Zanubrutinib n=80 Participants 160 mg administered orally (two - 80 mg white opaque capsules) twice a day (BID) for up to 3.5 years or until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by the sponsor.
Time to Response (TTR)	2.79 Months Interval 2.6 to 16.8

SECONDARY outcome

Timeframe: up to 3.5 years

Population: The Safety Analysis Set included all participants who received ≥ 1 doses of study drug.

Overall response was defined as achieving a best overall response of CR, CRi, nodular partial response (nPR), PR, or partial response with lymphocytosis (PR-L).

Outcome measures

Outcome measures
Measure	Zanubrutinib n=91 Participants 160 mg administered orally (two - 80 mg white opaque capsules) twice a day (BID) for up to 3.5 years or until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by the sponsor.
Overall Response Rate as Determined by the Investigator	92.3 Percentage of participants Interval 84.79 to 96.85

SECONDARY outcome

Timeframe: Up to 3.5 years

Population: The Safety Analysis Set included all participants who received ≥ 1 doses of study drug.

An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All AEs were monitored per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version \[v\] 4.03 2010). A treatment emergent adverse event (TEAE) is defined as an adverse event that has an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation or initiation of new anticancer therapy, whichever occurs first.

Outcome measures

Outcome measures
Measure	Zanubrutinib n=91 Participants 160 mg administered orally (two - 80 mg white opaque capsules) twice a day (BID) for up to 3.5 years or until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by the sponsor.
Number of Participants Experiencing Adverse Events (AEs) At Least 1 TEAE	91 Participants
Number of Participants Experiencing Adverse Events (AEs) Grade 3 or higher TEAE	76 Participants
Number of Participants Experiencing Adverse Events (AEs) Serious TEAEs	47 Participants
Number of Participants Experiencing Adverse Events (AEs) TEAE leading to death	6 Participants
Number of Participants Experiencing Adverse Events (AEs) TEAE leading to treatment discontinuation	14 Participants
Number of Participants Experiencing Adverse Events (AEs) TEAE leading to treatment modification	42 Participants
Number of Participants Experiencing Adverse Events (AEs) TEAE leading to treatment interruption	42 Participants
Number of Participants Experiencing Adverse Events (AEs) TEAE leading to dose reduction	8 Participants
Number of Participants Experiencing Adverse Events (AEs) Treatment-related TEAE	90 Participants

Adverse Events

Zanubrutinib

Serious events: 47 serious events

Other events: 91 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	Zanubrutinib n=91 participants at risk 160 mg administered orally (two - 80 mg white opaque capsules) twice a day (BID) for up to three years
Blood and lymphatic system disorders Anaemia	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Cardiac disorders Cardiac failure	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Cardiac disorders Cardiopulmonary failure	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Cardiac disorders Myocardial ischaemia	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Gastrointestinal disorders Intestinal obstruction	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
General disorders Multiple organ dysfunction syndrome	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Hepatobiliary disorders Cholecystitis	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Anorectal infection	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Bronchitis	3.3% 3/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Dermatitis infected	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Gastroenteritis	2.2% 2/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Hepatitis B	3.3% 3/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Lung infection	7.7% 7/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Pneumonia	24.2% 22/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Pneumonia fungal	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Skin infection	2.2% 2/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Splenic infection	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Upper respiratory tract infection	4.4% 4/91 • Up to 3.5 years Safety Analysis Set
Injury, poisoning and procedural complications Hand fracture	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Nervous system disorders Haemorrhage intracranial	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Nervous system disorders Headache	2.2% 2/91 • Up to 3.5 years Safety Analysis Set
Nervous system disorders Post herpetic neuralgia	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Respiratory, thoracic and mediastinal disorders Bronchiectasis	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Skin and subcutaneous tissue disorders Rash maculo-papular	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Endocrine disorders Goitre	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Gastrointestinal disorders Haemorrhoids	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Gastrointestinal disorders Intestinal polyp	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
General disorders Death	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Appendicitis	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Cryptococcosis	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Enteritis infectious	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Infectious pleural effusion	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Injury, poisoning and procedural complications Brain herniation	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Injury, poisoning and procedural complications Periprosthetic fracture	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Investigations Neutrophil count decreased	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Investigations Platelet count decreased	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Investigations Osteoarthropathy	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	2.2% 2/91 • Up to 3.5 years Safety Analysis Set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Nervous system disorders Cerebrovascular insufficiency	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Renal and urinary disorders Hydronephrosis	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Renal and urinary disorders Ureterolithiasis	1.1% 1/91 • Up to 3.5 years Safety Analysis Set
Reproductive system and breast disorders Benign prostatic hyperplasia	1.1% 1/91 • Up to 3.5 years Safety Analysis Set

Other adverse events

Other adverse events
Measure	Zanubrutinib n=91 participants at risk 160 mg administered orally (two - 80 mg white opaque capsules) twice a day (BID) for up to three years
Blood and lymphatic system disorders Anaemia	35.2% 32/91 • Up to 3.5 years Safety Analysis Set
Blood and lymphatic system disorders Thrombocytopenia	13.2% 12/91 • Up to 3.5 years Safety Analysis Set
Gastrointestinal disorders Abdominal distension	7.7% 7/91 • Up to 3.5 years Safety Analysis Set
Gastrointestinal disorders Abdominal pain upper	8.8% 8/91 • Up to 3.5 years Safety Analysis Set
Gastrointestinal disorders Constipation	9.9% 9/91 • Up to 3.5 years Safety Analysis Set
Gastrointestinal disorders Diarrhoea	22.0% 20/91 • Up to 3.5 years Safety Analysis Set
Gastrointestinal disorders Toothache	8.8% 8/91 • Up to 3.5 years Safety Analysis Set
Gastrointestinal disorders Vomiting	8.8% 8/91 • Up to 3.5 years Safety Analysis Set
General disorders Influenza like illness	5.5% 5/91 • Up to 3.5 years Safety Analysis Set
General disorders Pyrexia	13.2% 12/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Bronchitis	8.8% 8/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Paronychia	5.5% 5/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Pharyngitis	9.9% 9/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Skin infection	12.1% 11/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Upper respiratory tract infection	54.9% 50/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Urinary tract infection	19.8% 18/91 • Up to 3.5 years Safety Analysis Set
Investigations Alanine aminotransferase increased	17.6% 16/91 • Up to 3.5 years Safety Analysis Set
Investigations Aspartate aminotransferase increased	15.4% 14/91 • Up to 3.5 years Safety Analysis Set
Investigations Bacterial test positive	6.6% 6/91 • Up to 3.5 years Safety Analysis Set
Investigations Blood alkaline phosphatase increased	7.7% 7/91 • Up to 3.5 years Safety Analysis Set
Investigations Blood bilirubin increased	16.5% 15/91 • Up to 3.5 years Safety Analysis Set
Investigations Blood fibrinogen decreased	6.6% 6/91 • Up to 3.5 years Safety Analysis Set
Investigations Blood lactate dehydrogenase increased	5.5% 5/91 • Up to 3.5 years Safety Analysis Set
Investigations Blood urine present	13.2% 12/91 • Up to 3.5 years Safety Analysis Set
Investigations Carbon dioxide increased	25.3% 23/91 • Up to 3.5 years Safety Analysis Set
Investigations Electrocardiogram QT prolonged	8.8% 8/91 • Up to 3.5 years Safety Analysis Set
Investigations Neutrophil count decreased	76.9% 70/91 • Up to 3.5 years Safety Analysis Set
Investigations Neutrophil percentage decreased	8.8% 8/91 • Up to 3.5 years Safety Analysis Set
Investigations Platelet count decreased	42.9% 39/91 • Up to 3.5 years Safety Analysis Set
Investigations Red blood cells urine positive	8.8% 8/91 • Up to 3.5 years Safety Analysis Set
Investigations Urobilinogen urine increased	17.6% 16/91 • Up to 3.5 years Safety Analysis Set
Investigations White blood cell count decreased	25.3% 23/91 • Up to 3.5 years Safety Analysis Set
Metabolism and nutrition disorders Hyperglycaemia	28.6% 26/91 • Up to 3.5 years Safety Analysis Set
Metabolism and nutrition disorders Hyperuricaemia	19.8% 18/91 • Up to 3.5 years Safety Analysis Set
Metabolism and nutrition disorders Hypoalbuminaemia	13.2% 12/91 • Up to 3.5 years Safety Analysis Set
Metabolism and nutrition disorders Hypocalcaemia	14.3% 13/91 • Up to 3.5 years Safety Analysis Set
Metabolism and nutrition disorders Hypokalaemia	30.8% 28/91 • Up to 3.5 years Safety Analysis Set
Metabolism and nutrition disorders Hyponatraemia	11.0% 10/91 • Up to 3.5 years Safety Analysis Set
Nervous system disorders Dizziness	7.7% 7/91 • Up to 3.5 years Safety Analysis Set
Renal and urinary disorders Haematuria	44.0% 40/91 • Up to 3.5 years Safety Analysis Set
Renal and urinary disorders Proteinuria	16.5% 15/91 • Up to 3.5 years Safety Analysis Set
Respiratory, thoracic and mediastinal disorders Cough	29.7% 27/91 • Up to 3.5 years Safety Analysis Set
Respiratory, thoracic and mediastinal disorders Epistaxis	5.5% 5/91 • Up to 3.5 years Safety Analysis Set
Skin and subcutaneous tissue disorders Haemorrhage subcutaneous	7.7% 7/91 • Up to 3.5 years Safety Analysis Set
Skin and subcutaneous tissue disorders Purpura	34.1% 31/91 • Up to 3.5 years Safety Analysis Set
Skin and subcutaneous tissue disorders Rash	18.7% 17/91 • Up to 3.5 years Safety Analysis Set
Skin and subcutaneous tissue disorders Rash maculo-papular	5.5% 5/91 • Up to 3.5 years Safety Analysis Set
Vascular disorders Hypertension	11.0% 10/91 • Up to 3.5 years Safety Analysis Set
Blood and lymphatic system disorders Neutropenia	4.4% 4/91 • Up to 3.5 years Safety Analysis Set
Cardiac disorders Sinus bradycardia	3.3% 3/91 • Up to 3.5 years Safety Analysis Set
Gastrointestinal disorders Gastritis	5.5% 5/91 • Up to 3.5 years Safety Analysis Set
Gastrointestinal disorders Dyspepsia	4.4% 4/91 • Up to 3.5 years Safety Analysis Set
Gastrointestinal disorders Periodontal disease	4.4% 4/91 • Up to 3.5 years Safety Analysis Set
Gastrointestinal disorders Abdominal pain	3.3% 3/91 • Up to 3.5 years Safety Analysis Set
Gastrointestinal disorders Gastrooesophageal reflux disease	3.3% 3/91 • Up to 3.5 years Safety Analysis Set
Gastrointestinal disorders Mouth ulceration	3.3% 3/91 • Up to 3.5 years Safety Analysis Set
Gastrointestinal disorders Nausea	3.3% 3/91 • Up to 3.5 years Safety Analysis Set
General disorders Oedema peripheral	3.3% 3/91 • Up to 3.5 years Safety Analysis Set
General disorders Fatigue	3.3% 3/91 • Up to 3.5 years Safety Analysis Set
Hepatobiliary disorders Hyperbilirubinaemia	6.6% 6/91 • Up to 3.5 years Safety Analysis Set
Hepatobiliary disorders Hepatic function abnormal	4.4% 4/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Pneumonia	26.4% 24/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Herpes zoster	7.7% 7/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Gastroenteritis	5.5% 5/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Gingivitis	5.5% 5/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Periodontitis	5.5% 5/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Sinusitis	5.5% 5/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Asymptomatic bacteriuria	4.4% 4/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Oral herpes	4.4% 4/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Hepatitis B reactivation	3.3% 3/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Rash pustular	3.3% 3/91 • Up to 3.5 years Safety Analysis Set
Infections and infestations Tonsillitis	3.3% 3/91 • Up to 3.5 years Safety Analysis Set
Injury, poisoning and procedural complications Ligament sprain	3.3% 3/91 • Up to 3.5 years Safety Analysis Set
Investigations Gamma-glutamyltransferase increased	8.8% 8/91 • Up to 3.5 years Safety Analysis Set
Investigations Low density lipoprotein decreased	8.8% 8/91 • Up to 3.5 years Safety Analysis Set
Investigations Lymphocyte count decreased	8.8% 8/91 • Up to 3.5 years Safety Analysis Set
Investigations Blood creatinine increased	7.7% 7/91 • Up to 3.5 years Safety Analysis Set
Investigations Hepatitis B core antibody positive	6.6% 6/91 • Up to 3.5 years Safety Analysis Set
Investigations High density lipoprotein decreased	6.6% 6/91 • Up to 3.5 years Safety Analysis Set
Investigations Weight decreased	6.6% 6/91 • Up to 3.5 years Safety Analysis Set
Investigations Blood glucose increased	4.4% 4/91 • Up to 3.5 years Safety Analysis Set
Investigations Globulins decreased	4.4% 4/91 • Up to 3.5 years Safety Analysis Set
Investigations Haemoglobin decreased	4.4% 4/91 • Up to 3.5 years Safety Analysis Set
Investigations High density lipoprotein increased	4.4% 4/91 • Up to 3.5 years Safety Analysis Set
Investigations White blood cells urine positive	4.4% 4/91 • Up to 3.5 years Safety Analysis Set
Investigations Blood immunoglobulin A decreased	3.3% 3/91 • Up to 3.5 years Safety Analysis Set
Investigations Carbon dioxide decreased	3.3% 3/91 • Up to 3.5 years Safety Analysis Set
Investigations Urine leukocyte esterase positive	3.3% 3/91 • Up to 3.5 years Safety Analysis Set
Investigations White blood cell count increased	3.3% 3/91 • Up to 3.5 years Safety Analysis Set
Metabolism and nutrition disorders Hypertriglyceridaemia	7.7% 7/91 • Up to 3.5 years Safety Analysis Set
Metabolism and nutrition disorders Hyperlipidaemia	6.6% 6/91 • Up to 3.5 years Safety Analysis Set
Metabolism and nutrition disorders Hypercholesterolaemia	5.5% 5/91 • Up to 3.5 years Safety Analysis Set
Metabolism and nutrition disorders Hypercalcaemia	4.4% 4/91 • Up to 3.5 years Safety Analysis Set
Metabolism and nutrition disorders Hypophosphataemia	4.4% 4/91 • Up to 3.5 years Safety Analysis Set
Musculoskeletal and connective tissue disorders Back pain	4.4% 4/91 • Up to 3.5 years Safety Analysis Set
Nervous system disorders Headache	6.6% 6/91 • Up to 3.5 years Safety Analysis Set
Reproductive system and breast disorders Benign prostatic hyperplasia	4.4% 4/91 • Up to 3.5 years Safety Analysis Set
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.6% 6/91 • Up to 3.5 years Safety Analysis Set
Respiratory, thoracic and mediastinal disorders Nasal obstruction	4.4% 4/91 • Up to 3.5 years Safety Analysis Set
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	4.4% 4/91 • Up to 3.5 years Safety Analysis Set
Skin and subcutaneous tissue disorders Dermatitis allergic	3.3% 3/91 • Up to 3.5 years Safety Analysis Set
Skin and subcutaneous tissue disorders Ecchymosis	3.3% 3/91 • Up to 3.5 years Safety Analysis Set
Skin and subcutaneous tissue disorders Pruritus	3.3% 3/91 • Up to 3.5 years Safety Analysis Set
Skin and subcutaneous tissue disorders Skin haemorrhage	3.3% 3/91 • Up to 3.5 years Safety Analysis Set

Additional Information

Study Director

BeiGene

Phone: +1-877-828-5568

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
Publication restrictions are in place

Restriction type: OTHER