Trial Outcomes & Findings for Study to Assess Effect of Oral Venetoclax Tablet in Combination With Oral Ibrutinib Capsule on Best Overall Response of Complete Response in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma (NCT NCT04477486)
NCT ID: NCT04477486
Last Updated: 2025-07-09
Results Overview
Complete response rate (CRR), defined as the percentage of participants achieving a best overall response of complete response (CR) per the Revised Criteria for Response Assessment for Malignant Lymphoma following the Lugano classification (Cheson 2014), assessed by an Independent Review Committee (IRC).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Week 13
Results posted on
2025-07-09
Participant Flow
A total of 13 participants were enrolled across 12 sites in Japan.
The Full Analysis Set (FAS) included all participants who received at least one dose of study drug and was used for all efficacy analyses (except for those based on IRC assessment), safety, and baseline analyses (N=13). The Per-protocol (PP) population excluded participants with non-evaluable disease at baseline (based on IRC assessment). PP population was used for IRC-assessed endpoints (N=12).
Participant milestones
| Measure |
Ibrutinib + Venetoclax
Participants received Ibrutinib 560 mg once daily (QD) + Venetoclax starting at 20 mg QD, gradually ramped up over 5 weeks to a target dose of 400 mg QD. Ibrutinib 560 mg QD + Venetoclax 400 mg QD was continued for up to 104 weeks, followed by 560 mg QD Ibrutinib monotherapy.
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|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Ibrutinib + Venetoclax
Participants received Ibrutinib 560 mg once daily (QD) + Venetoclax starting at 20 mg QD, gradually ramped up over 5 weeks to a target dose of 400 mg QD. Ibrutinib 560 mg QD + Venetoclax 400 mg QD was continued for up to 104 weeks, followed by 560 mg QD Ibrutinib monotherapy.
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|---|---|
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Overall Study
Death
|
2
|
|
Overall Study
Ongoing at Time of Analysis
|
11
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Baseline Characteristics
Study to Assess Effect of Oral Venetoclax Tablet in Combination With Oral Ibrutinib Capsule on Best Overall Response of Complete Response in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Ibrutinib + Venetoclax
n=13 Participants
Participants received Ibrutinib 560 mg QD + Venetoclax starting at 20 mg QD, gradually ramped up over 5 weeks to a target dose of 400 mg QD. Ibrutinib 560 mg QD + Venetoclax 400 mg QD was continued for up to 104 weeks, followed by Ibrutinib monotherapy.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
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2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
69.8 Years
STANDARD_DEVIATION 5.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 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
|
13 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
Japan
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13 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Week 13Population: Per-Protocol Population
Complete response rate (CRR), defined as the percentage of participants achieving a best overall response of complete response (CR) per the Revised Criteria for Response Assessment for Malignant Lymphoma following the Lugano classification (Cheson 2014), assessed by an Independent Review Committee (IRC).
Outcome measures
| Measure |
Ibrutinib + Venetoclax
n=12 Participants
Participants received Ibrutinib 560 mg QD + Venetoclax starting at 20 mg QD, gradually ramped up over 5 weeks to a target dose of 400 mg QD. Ibrutinib 560 mg QD + Venetoclax 400 mg QD was continued for up to 104 weeks, followed by Ibrutinib monotherapy.
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|---|---|
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Percentage of Participants Achieving Best Overall Response of Complete Response (CR), as Assessed by the Independent Review Committee (IRC)
|
83.3 percentage of participants
Interval 51.6 to 97.9
|
SECONDARY outcome
Timeframe: Week 104Overall Response Rate (ORR), defined as the percentage of participants with a best overall response of CR or PR, per the Revised Criteria for Response Assessment for Malignant Lymphoma, assessed by an Independent Review Committee (IRC).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 104Best overall response of CR is defined as the percentage of participants achieving a best overall response of CR for the venetoclax and ibrutinib combination, as assessed by the investigator per the Revised Criteria for Response Assessment for Malignant Lymphoma .
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 104Best overall response of CR or PR will be evaluated using ORR. The ORR is defined as the percentage of participants with a best overall response of CR or PR, according to the Revised Criteria for Response Assessment for Malignant Lymphoma, as assessed by the investigator.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 104DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first, according to the Revised Criteria for Response Assessment for Malignant Lymphoma, as assessed by the investigator.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 104DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first, according to the Revised Criteria for Response Assessment for Malignant Lymphoma, as assessed by the IRC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 104MRD rate is defined as the percentage of participants with uMRD who achieve a best overall response of CR, according to the Revised Criteria for Response Assessment for Malignant Lymphoma, as assessed by the investigator.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 104MRD rate is defined as the percentage of participants with uMRD who achieve a best overall response of CR, according to the Revised Criteria for Response Assessment for Malignant Lymphoma, as assessed by the IRC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 104PFS is defined as the time from the date of the first dose of study drug (venetoclax or ibrutinib) to the date of investigator-assessed disease progression, using the Revised Response Criteria for Response Assessment for Malignant Lymphoma, or death from any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 104OS is defined as the time from the date of the first dose of the study drug (venetoclax or ibrutinib) to death from any cause.
Outcome measures
Outcome data not reported
Adverse Events
Venetoclax + Ibrutinib
Serious events: 2 serious events
Other events: 13 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Venetoclax + Ibrutinib
n=13 participants at risk
Participants received Ibrutinib 560 mg QD + Venetoclax starting at 20 mg QD, gradually ramped up over 5 weeks to a target dose of 400 mg QD. Ibrutinib 560 mg QD + Venetoclax 400 mg QD was continued for up to 104 weeks, followed by Ibrutinib monotherapy.
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|---|---|
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Blood and lymphatic system disorders
NEUTROPENIA
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Infections and infestations
SEPSIS
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF LUNG
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
Other adverse events
| Measure |
Venetoclax + Ibrutinib
n=13 participants at risk
Participants received Ibrutinib 560 mg QD + Venetoclax starting at 20 mg QD, gradually ramped up over 5 weeks to a target dose of 400 mg QD. Ibrutinib 560 mg QD + Venetoclax 400 mg QD was continued for up to 104 weeks, followed by Ibrutinib monotherapy.
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|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
30.8%
4/13 • Number of events 7 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
30.8%
4/13 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
23.1%
3/13 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
15.4%
2/13 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Cardiac disorders
CARDIAC FAILURE
|
7.7%
1/13 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Gastrointestinal disorders
CHEILITIS
|
7.7%
1/13 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Gastrointestinal disorders
CONSTIPATION
|
15.4%
2/13 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Gastrointestinal disorders
DIARRHOEA
|
53.8%
7/13 • Number of events 8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Gastrointestinal disorders
NAUSEA
|
23.1%
3/13 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Gastrointestinal disorders
STOMATITIS
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Gastrointestinal disorders
TOOTHACHE
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Gastrointestinal disorders
VOMITING
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
General disorders
GENERALISED OEDEMA
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
General disorders
INJECTION SITE PAIN
|
7.7%
1/13 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
General disorders
MALAISE
|
7.7%
1/13 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
General disorders
MUCOSAL INFLAMMATION
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
General disorders
PYREXIA
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Immune system disorders
HYPERSENSITIVITY
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Infections and infestations
BODY TINEA
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Infections and infestations
CANDIDA INFECTION
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Infections and infestations
GASTROENTERITIS
|
7.7%
1/13 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Infections and infestations
HERPES ZOSTER
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Infections and infestations
IMPETIGO
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Infections and infestations
LOCALISED INFECTION
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Infections and infestations
PERIODONTITIS
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Infections and infestations
PHARYNGITIS
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Infections and infestations
PNEUMONIA
|
15.4%
2/13 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Infections and infestations
SKIN INFECTION
|
23.1%
3/13 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
15.4%
2/13 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Investigations
WEIGHT INCREASED
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
23.1%
3/13 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
7.7%
1/13 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
15.4%
2/13 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
15.4%
2/13 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
15.4%
2/13 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ANOGENITAL WARTS
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Nervous system disorders
DIZZINESS
|
7.7%
1/13 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Nervous system disorders
DYSGEUSIA
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Nervous system disorders
HEADACHE
|
15.4%
2/13 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGEAL ERYTHEMA
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY TRACT OEDEMA
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
15.4%
2/13 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Skin and subcutaneous tissue disorders
RASH
|
7.7%
1/13 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
7.7%
1/13 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Vascular disorders
HYPERTENSION
|
15.4%
2/13 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
|
Vascular disorders
VASCULAR PAIN
|
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to interim data cut (09 February 2022). Median time participants were followed was 36.1 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER