Trial Outcomes & Findings for A Study of Ibrutinib (PCI-32765) in Chinese Participants With Relapse or Refractory Waldenstrom's Macroglobulinemia (WM) (NCT NCT04042376)
NCT ID: NCT04042376
Last Updated: 2025-05-25
Results Overview
ORR was defined as the percentage of participants who achieved partial response (PR) or better (VGPR) per the modified consensus response criteria from sixth International Workshop on Waldenstrom's Macroglobulinemia (IWWM) (National Comprehensive Cancer Network \[NCCN\], 2019). PR: greater than or equal to (\>=) 50 percent (%) reduction of serum immunoglobulin M (IgM) from baseline, with reduction in lymphadenopathy/splenomegaly if present at baseline. Very Good Partial Response (VGPR): \>=90% reduction of serum IgM from baseline or normal serum IgM values, with reduction in lymphadenopathy/splenomegaly if present at baseline.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
17 participants
Primary outcome timeframe
From start of the treatment (Day 1) up to 49.3 months
Results posted on
2025-05-25
Participant Flow
Participant milestones
| Measure |
Ibrutinib 420 mg
Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first.
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Overall Study
STARTED
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17
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Overall Study
COMPLETED
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13
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
| Measure |
Ibrutinib 420 mg
Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first.
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Overall Study
Withdrawal by Subject
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1
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Overall Study
Death
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3
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Baseline Characteristics
A Study of Ibrutinib (PCI-32765) in Chinese Participants With Relapse or Refractory Waldenstrom's Macroglobulinemia (WM)
Baseline characteristics by cohort
| Measure |
Ibrutinib 420 mg
n=17 Participants
Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first.
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Age, Continuous
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64.1 Years
STANDARD_DEVIATION 6.95 • n=5 Participants
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Sex: Female, Male
Female
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7 Participants
n=5 Participants
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Sex: Female, Male
Male
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10 Participants
n=5 Participants
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Race/Ethnicity, Customized
Asian/Not Hispanic or Latino
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17 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: From start of the treatment (Day 1) up to 49.3 monthsPopulation: All treated analysis set included all enrolled participants who received at least 1 dose of study drug.
ORR was defined as the percentage of participants who achieved partial response (PR) or better (VGPR) per the modified consensus response criteria from sixth International Workshop on Waldenstrom's Macroglobulinemia (IWWM) (National Comprehensive Cancer Network \[NCCN\], 2019). PR: greater than or equal to (\>=) 50 percent (%) reduction of serum immunoglobulin M (IgM) from baseline, with reduction in lymphadenopathy/splenomegaly if present at baseline. Very Good Partial Response (VGPR): \>=90% reduction of serum IgM from baseline or normal serum IgM values, with reduction in lymphadenopathy/splenomegaly if present at baseline.
Outcome measures
| Measure |
Ibrutinib 420 mg
n=17 Participants
Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first.
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Overall Response Rate (ORR)
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70.6 Percentage of Participants
Interval 47.8 to 87.6
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SECONDARY outcome
Timeframe: From start of the treatment (Day 1) up to 49.3 monthsPopulation: All treated analysis set included all enrolled participants who received at least 1 dose of study drug.
CRR was defined as the percentage of participants who achieved minor response (MR) or better according to the modified sixth IWWM (NCCN 2019) criteria as assessed by the investigator. MR: \>=25% but less than (\<) 50% reduction of serum IgM from baseline.
Outcome measures
| Measure |
Ibrutinib 420 mg
n=17 Participants
Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first.
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Clinical Response Rate (CRR)
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100.0 Percentage of Participants
Interval 83.8 to 100.0
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SECONDARY outcome
Timeframe: From start of the treatment (Day 1) up to 49.3 monthsPopulation: All treated analysis set included all enrolled participants who received at least 1 dose of study drug.
VGPR or better response rate was defined as the percentage of participants who achieved VGPR or better according to the modified sixth IWWM (NCCN 2019) criteria as assessed by the investigator. VGPR: \>=90% reduction of serum IgM from baseline or normal serum IgM values, with reduction in lymphadenopathy/splenomegaly if present at baseline.
Outcome measures
| Measure |
Ibrutinib 420 mg
n=17 Participants
Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first.
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Very Good Partial Response (VGPR) or Better Response Rate
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5.9 Percentage of Participants
Interval 0.3 to 25.0
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SECONDARY outcome
Timeframe: From the date of first documented response up to date of first documented PD or death (Day 1 up to 49.3 months)Population: Analysis population included responders in all treated analysis set who achieved PR or better.
DOR: duration from date of initial documentation of response (PR/better) to date of first documented progressive disease(PD), death or date of censoring if applicable, for responders (PR/better), as assessed by investigator. VGPR/PR: \>=90% reduction or normal serum IgM values (for VGPR) and \>=50% (for PR) reduction of serum IgM, with reduction in lymphadenopathy/splenomegaly if present at baseline. PD(at least 1): \>=25% IgM increase in serum IgM with \>=500 milligrams per deciliters(mg/dL) increase from nadir(lowest serum IgM value at any time from baseline), confirmation needed if IgM was sole PD criterion; new lymph nodes \>1.5 centimeters(cm), \>=50% increase in nadir in sum of product of diameters; 50% increase in longest diameter of previously identified node \>1cm in short axis; new splenomegaly; new extranodal disease; new/recurrent bone marrow involvement; new symptomatic disease(pleural effusion/Bing Neel syndrome/amyloidosis/light chain deposition/paraprotein mediated disorder).
Outcome measures
| Measure |
Ibrutinib 420 mg
n=12 Participants
Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first.
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Duration of Response (DOR)
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20.27 Months
Interval 11.07 to
Here, 'NA' signifies that upper limit of 95% confidence interval could not be estimated due to less number of participants with event.
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SECONDARY outcome
Timeframe: From start of the treatment up to first documentation of PR or better (Day 1 up to 49.3 months)Population: Analysis population included responders in all treated analysis set who achieved PR or better.
TTR was defined as the time from the date of first dose to the date of initial documentation of a response (PR or better) for responders. PR: \>=50% reduction of serum IgM from baseline, with reduction in lymphadenopathy/splenomegaly if present at baseline. VGPR: \>=90% reduction of serum IgM from baseline or normal serum IgM values, with reduction in lymphadenopathy/splenomegaly if present at baseline.
Outcome measures
| Measure |
Ibrutinib 420 mg
n=12 Participants
Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first.
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Time to Response (TTR)
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3.71 Months
Interval 1.84 to 3.71
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SECONDARY outcome
Timeframe: From day of first dose (Day 1) until PD or death (up to 49.3 months)Population: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Here, 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure.
PFS was defined as duration from the date of first dose to the date of disease progression or death, whichever occurs first, assessed according to the modified sixth IWWM (NCCN 2019) criteria. PD (at least 1 of the following): \>=25% IgM increase in serum IgM with \>=500 mg/dL increase from nadir (lowest serum IgM value at any time from baseline), confirmation needed if IgM was sole PD criterion; new lymph nodes \>1.5 cm, \>=50% increase in nadir in sum of product of diameters; 50% increase in longest diameter of previously identified node \>1 cm in short axis; new splenomegaly; new extranodal disease; new/recurrent bone marrow involvement; new symptomatic disease (pleural effusion, Bing Neel syndrome, amyloidosis, light chain deposition, paraprotein mediated disorder).
Outcome measures
| Measure |
Ibrutinib 420 mg
n=9 Participants
Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first.
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Progression Free Survival (PFS)
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23.95 Months
Interval 14.69 to
Here, 'NA' signifies that upper limit of 95% confidence interval could not be estimated due to less number of participants with event.
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SECONDARY outcome
Timeframe: From day of first dose (Day 1) until death due to any cause (up to 49.3 months)Population: All treated analysis set included all enrolled participants who received at least 1 dose of study drug.
Overall survival was measured from the date of first dose to the date of the participant's death from any cause.
Outcome measures
| Measure |
Ibrutinib 420 mg
n=17 Participants
Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first.
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Overall Survival (OS)
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NA Months
Here, 'NA' signifies that median, lower and upper limit of 95% confidence interval could not be estimated due to less number of participants with event.
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SECONDARY outcome
Timeframe: From start of the treatment (Day 1) up to 30 days after last dose or initiation of subsequent antineoplastic treatment, whichever occurred first (Day 1 up to 45.9 months)Population: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were defined as AEs occurring after the first dose of study drugs and within 30 days following the last dose of study drug or initiation of subsequent antineoplastic treatment, whichever occurred earlier. TEAEs were graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 as Grade 1= Mild; Grade 2= Moderate; Grade 3= Severe; Grade 4= Life-threatening and Grade 5= Death. Number of participants with TEAEs and Grade 3 or higher TEAEs (included serious and non-serious events) were reported in this outcome measure.
Outcome measures
| Measure |
Ibrutinib 420 mg
n=17 Participants
Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first.
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Grade 3 or Higher TEAEs
TEAEs
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17 Participants
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Grade 3 or Higher TEAEs
Grade 3 or Higher TEAEs
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15 Participants
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SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Weeks 1, 5 and 9Population: Pharmacokinetics (PK) evaluable analysis set included all enrolled participants who received at least 1 dose of ibrutinib and had at least 1 available PK sample after treatment. Here, 'n' (number analyzed) signifies number of participants evaluable for specified time point.
Plasma concentrations of ibrutinib were reported.
Outcome measures
| Measure |
Ibrutinib 420 mg
n=17 Participants
Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first.
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Plasma Concentration of Ibrutinib
Predose Day 1 Week 1
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NA Nanograms per milliliter (ng/mL)
Standard Deviation NA
Here, 'NA' signifies that mean and standard deviation could not be calculated as concentration was below quantification limit (\<0.500 ng/mL).
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Plasma Concentration of Ibrutinib
Predose Day 1 Week 5
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3.46 Nanograms per milliliter (ng/mL)
Standard Deviation 3.97
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Plasma Concentration of Ibrutinib
Predose Day 1 Week 9
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6.27 Nanograms per milliliter (ng/mL)
Standard Deviation 8.36
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Adverse Events
Ibrutinib 420 mg
Serious events: 9 serious events
Other events: 17 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Ibrutinib 420 mg
n=17 participants at risk
Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first.
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Infections and infestations
Anal Abscess
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5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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Infections and infestations
Bacterial Prostatitis
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5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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Infections and infestations
Covid-19 Pneumonia
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5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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Infections and infestations
Orchitis
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5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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Infections and infestations
Pneumonia
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5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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Injury, poisoning and procedural complications
Fracture
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5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
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5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Squamous Cell Carcinoma Stage 0
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5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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Nervous system disorders
Haemorrhage Intracranial
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5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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Nervous system disorders
Peripheral Sensory Neuropathy
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5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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Renal and urinary disorders
Ureterolithiasis
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5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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Respiratory, thoracic and mediastinal disorders
Pleural Effusion
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5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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Other adverse events
| Measure |
Ibrutinib 420 mg
n=17 participants at risk
Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first.
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Blood and lymphatic system disorders
Anaemia
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35.3%
6/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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Blood and lymphatic system disorders
Lymphopenia
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5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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Blood and lymphatic system disorders
Neutropenia
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5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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Cardiac disorders
Cardiac Failure
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5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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Cardiac disorders
Palpitations
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5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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Cardiac disorders
Ventricular Arrhythmia
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5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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Ear and labyrinth disorders
Vertigo
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5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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Eye disorders
Retinal Haemorrhage
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5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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Gastrointestinal disorders
Abdominal Pain
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5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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Gastrointestinal disorders
Abdominal Pain Upper
|
17.6%
3/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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Gastrointestinal disorders
Constipation
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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|
Gastrointestinal disorders
Diarrhoea
|
11.8%
2/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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|
Gastrointestinal disorders
Gastrointestinal Pain
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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|
Gastrointestinal disorders
Mouth Haemorrhage
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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|
General disorders
Oedema Peripheral
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Anal Abscess
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacterial Prostatitis
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Covid-19
|
11.8%
2/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Eye Infection
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gingivitis
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes Simplex
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes Zoster
|
11.8%
2/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Orchitis
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
11.8%
2/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
11.8%
2/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
29.4%
5/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary Tract Infection
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fracture
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Head Injury
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine Aminotransferase Increased
|
11.8%
2/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate Aminotransferase Increased
|
11.8%
2/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood Bilirubin Increased
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood Creatinine Increased
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood Urea Increased
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Hepatitis B DNA Assay Positive
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil Count Decreased
|
29.4%
5/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Platelet Count Decreased
|
17.6%
3/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Weight Decreased
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Weight Increased
|
17.6%
3/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
White Blood Cell Count Decreased
|
29.4%
5/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.8%
2/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
64.7%
11/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
29.4%
5/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.8%
2/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.8%
2/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Haemorrhage Intracranial
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuralgia
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal Failure
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Ureterolithiasis
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Haemorrhage
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
23.5%
4/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein Purpura
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
11.8%
2/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.8%
2/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Scalp Haematoma
|
5.9%
1/17 • All-cause mortality: From Day 1 up to 49.3 months; Serious and other adverse events: From first dose of study drug (Day 1) up to 30 days after last dose of study drug (up to 45.9 months)
All-cause mortality: All treated analysis set included all enrolled participants who received at least 1 dose of study drug. Serious and other adverse events: Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
|
Additional Information
Executive Medical Director Onc
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, 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 by the sponsor in writing, the investigator will delay to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER