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A Study of the Efficacy of ABT-199 in Subjects With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia With the 17p Deletion

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ClinicalTrials.gov Identifier: NCT01889186
Recruitment Status : Completed
First Posted : June 28, 2013
Results First Posted : December 16, 2021
Last Update Posted : December 16, 2021
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Lymphocytic Leukemia
17p Deletion
Cancer of the Blood and Bone Marrow
Interventions Drug: ABT-199 (Main Cohort)
Drug: ABT-199 (Safety Expansion Cohort)
Enrollment 158
Recruitment Details  
Pre-assignment Details All treated participants: all participants who received at least one dose of ABT-199 in either the Main Cohort or Safety Expansion Cohort
Arm/Group Title Main Cohort Safety Expansion Cohort
Hide Arm/Group Description Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Period Title: Overall Study
Started 107 51
Completed 0 0
Not Completed 107 51
Reason Not Completed
Adverse event- not related to progression             18             5
Adverse event- related to progression             7             2
COVID-19 logistical restrictions             1             0
Investigator request             1             1
Progressive disease- Richter's             12             7
Progressive disease per protocol             46             17
Stem cell transplant             2             1
Withdrew consent             2             3
Other, not specified             18             15
Arm/Group Title Main Cohort Safety Expansion Cohort Total
Hide Arm/Group Description Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Total of all reporting groups
Overall Number of Baseline Participants 107 51 158
Hide Baseline Analysis Population Description
All treated participants: all participants who received at least one dose of ABT-199 in either the Main Cohort or Safety Expansion Cohort
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 107 participants 51 participants 158 participants
65.7  (9.87) 65.4  (9.97) 65.6  (9.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 51 participants 158 participants
Female 37 22 59
Male 70 29 99
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 107 participants 51 participants 158 participants
White 103 49 152
Black 3 1 4
Asian 0 0 0
American Indian/Alaska Native 0 0 0
Native Hawaiian or other Pacific Islander 0 0 0
Other 0 0 0
Multi race 0 0 0
MISSING 1 1 2
1.Primary Outcome
Title Overall Response Rate (Main Cohort)
Hide Description The overall response rate (ORR) is defined as the proportion of participants with an overall response (complete remission [CR] + complete remission with incomplete marrow recovery [CRi] + nodular partial remission [nPR] + partial remission [PR]) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria as assessed by the Independent Review Committee (IRC) in the first 70 participants treated in the Main Cohort.
Time Frame Up to 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The first 70 participants who were treated with ABT-199 in the Main Cohort
Arm/Group Title Main Cohort
Hide Arm/Group Description:
Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Overall Number of Participants Analyzed 70
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
77.1
(65.6 to 86.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Main Cohort
Comments The ORR for ABT-199 was tested to reject the null hypothesis of ORR = 40%. If the null hypothesis is rejected and the ORR is higher than 40%, then ABT-199 has been shown to have an ORR significantly higher than 40%.The p-value is from the exact binomial distribution comparing ABT-199 ORR to the 40% historical control rate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Clopper-Pearson exact method
Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Adverse Events (Safety Expansion Cohort)
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Time Frame From the first dose of study drug until 30 days following last dose of study drug (up to 69 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in the Safety Expansion Cohort
Arm/Group Title Safety Expansion Cohort
Hide Arm/Group Description:
Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Overall Number of Participants Analyzed 51
Measure Type: Count of Participants
Unit of Measure: Participants
51
3.Secondary Outcome
Title Overall Response Rate (ORR) (Safety Expansion Cohort)
Hide Description The overall response rate (ORR) is defined as the proportion of participants with an overall response (complete remission [CR] + complete remission with incomplete marrow recovery [CRi] + nodular partial remission [nPR] + partial remission [PR]) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria.
Time Frame Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in the Safety Expansion Cohort
Arm/Group Title Safety Expansion Cohort
Hide Arm/Group Description:
Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Overall Number of Participants Analyzed 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
82.4
(69.1 to 91.6)
4.Secondary Outcome
Title Complete Remission (CR) Rate
Hide Description Complete remission was defined as the proportion of participants who achieved a CR or Complete Remission with Incomplete Marrow Recovery(CRi ) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria. Participants who did not achieve a CR or CRi were considered to be non-responders in the calculation of CR rate.
Time Frame Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in the Main Cohort and the Safety Expansion Cohort
Arm/Group Title Main Cohort Safety Expansion Cohort
Hide Arm/Group Description:
Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Overall Number of Participants Analyzed 107 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
21.5
(14.1 to 30.5)
27.5
(15.9 to 41.7)
5.Secondary Outcome
Title Partial Remission (PR) Rate
Hide Description PR rate was defined as the proportion of participants who achieved a nodular partial remission (nPR) or PR per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria. Participants who did not achieve a nPR or PR were considered to be non-responders in the calculation of PR rate.
Time Frame Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in the Main Cohort and the Safety Expansion Cohort
Arm/Group Title Main Cohort Safety Expansion Cohort
Hide Arm/Group Description:
Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Overall Number of Participants Analyzed 107 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
53.3
(43.4 to 63.0)
54.9
(40.3 to 68.9)
6.Secondary Outcome
Title Duration of Overall Response
Hide Description Duration of overall response (DoR) was defined as the number of days from the date of first response (CR, CRi, nPR, or PR) by either CT scan or physical exam determination to the earliest recurrence (progressive disease; PD) or death. For participants who had a PR before CR, CRi, or nPR in subsequent visits, the DoR was computed from the earliest PR. If a participant was still responding, then their data was censored at the date of their last available disease assessment. To be included in the DoR analysis, participants must have had a response per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria (CR, CRi, confirmed nPR, or confirmed PR). For participants who never experienced response, their data was not included in the analysis.
Time Frame Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in the Main Cohort and the Safety Expansion Cohort with a response and available data
Arm/Group Title Main Cohort Safety Expansion Cohort
Hide Arm/Group Description:
Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Overall Number of Participants Analyzed 80 42
Median (95% Confidence Interval)
Unit of Measure: months
35.3 [1] 
(26.5 to NA)
NA [1] 
(27.3 to NA)
[1]
Not calculable/estimable due to insufficient number of events
7.Secondary Outcome
Title Progression-free Survival
Hide Description Duration of progression-free survival (PFS) was defined as the number of days from the date of first dose to the date of earliest disease progression or death. All disease progression was included regardless of whether the event occurred while the participant was taking ABT-199 or had previously discontinued ABT-199. If the participant does not experience disease progression or death, then the data was censored at the date of last disease assessment. Data for participants without any disease assessments performed after the baseline visit were censored at the date of first dose plus 1 day.
Time Frame Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in the Main Cohort and the Safety Expansion Cohort with available data
Arm/Group Title Main Cohort Safety Expansion Cohort
Hide Arm/Group Description:
Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Overall Number of Participants Analyzed 107 51
Median (95% Confidence Interval)
Unit of Measure: months
24.7
(21.7 to 35.9)
30.2 [1] 
(24.7 to NA)
[1]
Not calculable/estimable due to insufficient number of events
8.Secondary Outcome
Title Event-free Survival
Hide Description Event-free survival (EFS) was defined as the number of days from the date of first dose to the date of earliest disease progression, death, or start of a new anti-leukemic therapy. If the specified event (disease progression, death, start of a new anti-leukemic treatment) did not occur, participants were censored at the date of last disease assessment. Data for participants without any disease assessments performed after the baseline visit were censored at the date of first dose plus 1 day.
Time Frame Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in the Main Cohort and the Safety Expansion Cohort with available data
Arm/Group Title Main Cohort Safety Expansion Cohort
Hide Arm/Group Description:
Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Overall Number of Participants Analyzed 107 51
Median (95% Confidence Interval)
Unit of Measure: months
24.7
(19.7 to 35.9)
30.2 [1] 
(24.7 to NA)
[1]
Not calculable/estimable due to insufficient number of events
9.Secondary Outcome
Title Time to Progression
Hide Description Time to progression (TTP) was defined as the number of days from the date of first dose to the date of earliest disease progression. All disease progression was included regardless of whether the event occurred while the participant was taking ABT-199 or had previously discontinued ABT-199. If the participant did not experience disease progression, then the data was censored at the date of last available disease assessment. Data for participants without any disease assessments performed after the baseline visit were censored at the date of first dose plus 1 day.
Time Frame Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in the Main Cohort and the Safety Expansion Cohort with available data
Arm/Group Title Main Cohort Safety Expansion Cohort
Hide Arm/Group Description:
Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Overall Number of Participants Analyzed 107 51
Median (95% Confidence Interval)
Unit of Measure: months
28.2
(21.9 to 39.0)
30.2 [1] 
(27.0 to NA)
[1]
Not calculable/estimable due to insufficient number of events
10.Secondary Outcome
Title Time to First Response
Hide Description Time to first response was defined as the number of days from the date of first dose to the date of the first sign of response (CR, CRi, nPR, or PR) given the participant has had a CR, CRi, confirmed nPR, or confirmed PR per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria. The first response could have been an assessment by physical exam as long as the results were later confirmed per the 2008 Modified IWCLL NCI-WG criteria. For participants who never experienced a response, the participant's data were not included in the analysis.
Time Frame Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in the Main Cohort and the Safety Expansion Cohort with a response and available data
Arm/Group Title Main Cohort Safety Expansion Cohort
Hide Arm/Group Description:
Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Overall Number of Participants Analyzed 80 42
Mean (95% Confidence Interval)
Unit of Measure: months
1.1
(1.0 to 1.3)
1.3
(1.1 to 1.5)
11.Secondary Outcome
Title Time to 50% Reduction in Absolute Lymphocyte Count
Hide Description Time to 50% reduction in absolute lymphocyte count (ALC) was defined as the number of days (hours if applicable) from the date of first dose to the date when the ALC had reduced to 50% of the baseline value. Only participants with a baseline of ALC > 5 × 10^9 /L were included in the analysis. For participants who never achieved a 50% reduction in ALC, the participant's data were not included in the analysis.
Time Frame Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with a baseline of ALC > 5 × 10^9 /L, a 50% reduction in ALC, and available data
Arm/Group Title Main Cohort All Treated Participants
Hide Arm/Group Description:
Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Participants in the Main Cohort received ABT-199 tablets once daily (QD) orally for up to 79 months,and those in the Safety Expansion Cohort received ABT-199 tablets once daily (QD) orally for up to 68 months. For both groups, the starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Overall Number of Participants Analyzed 85 125
Mean (95% Confidence Interval)
Unit of Measure: weeks
1.1
(0.9 to 1.2)
1.2
(1.1 to 1.4)
12.Secondary Outcome
Title Overall Survival
Hide Description Overall survival (OS) was defined as number of days from the date of first dose to the date of death. For participants who did not die, their data was censored at the date of last study visit or the last known date to be alive, whichever was later.
Time Frame Up to the data cutoff date of 15 December 2020, approximately 7.5 years of follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with available data
Arm/Group Title Main Cohort Safety Expansion Cohort
Hide Arm/Group Description:
Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Overall Number of Participants Analyzed 107 51
Median (95% Confidence Interval)
Unit of Measure: months
53.4
(37.0 to 73.0)
NA [1] 
(61.6 to NA)
[1]
Not calculable/estimable due to insufficient number of events
13.Secondary Outcome
Title Percentage of Participants Who Moved on to Stem Cell Transplant
Hide Description The percentage of participants who moved on to stem cell transplant was summarized.
Time Frame Up to the data cutoff date of 15 June 2017, approximately 4 years of follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with available data
Arm/Group Title Main Cohort All Treated Participants
Hide Arm/Group Description:
Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Participants in the Main Cohort received ABT-199 tablets once daily (QD) orally for up to 79 months,and those in the Safety Expansion Cohort received ABT-199 tablets once daily (QD) orally for up to 68 months. For both groups, the starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
Overall Number of Participants Analyzed 107 158
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2.8
(0.6 to 8.0)
2.5
(0.7 to 6.4)
Time Frame Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 80 months for the Main Cohort and up to 69 months for the Safety Expansion Cohort.
Adverse Event Reporting Description TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
 
Arm/Group Title Main Cohort Safety Expansion Cohort
Hide Arm/Group Description Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
All-Cause Mortality
Main Cohort Safety Expansion Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   62/107 (57.94%)      19/51 (37.25%)    
Hide Serious Adverse Events
Main Cohort Safety Expansion Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   78/107 (72.90%)      34/51 (66.67%)    
Blood and lymphatic system disorders     
ANAEMIA † 1  4/107 (3.74%)  4 1/51 (1.96%)  1
AUTOIMMUNE HAEMOLYTIC ANAEMIA † 1  7/107 (6.54%)  10 1/51 (1.96%)  1
FEBRILE NEUTROPENIA † 1  7/107 (6.54%)  9 2/51 (3.92%)  2
HAEMOLYSIS † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
HAEMORRHAGIC DIATHESIS † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
IMMUNE THROMBOCYTOPENIA † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
LYMPHADENOPATHY † 1  3/107 (2.80%)  3 1/51 (1.96%)  1
NEUTROPENIA † 1  2/107 (1.87%)  2 2/51 (3.92%)  2
THROMBOCYTOPENIA † 1  3/107 (2.80%)  3 1/51 (1.96%)  1
Cardiac disorders     
ACUTE CORONARY SYNDROME † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
ACUTE MYOCARDIAL INFARCTION † 1  1/107 (0.93%)  1 1/51 (1.96%)  1
ANGINA PECTORIS † 1  2/107 (1.87%)  2 1/51 (1.96%)  1
ATRIAL FIBRILLATION † 1  3/107 (2.80%)  3 0/51 (0.00%)  0
ATRIAL FLUTTER † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
ATRIOVENTRICULAR BLOCK SECOND DEGREE † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
CARDIAC ARREST † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
CARDIOGENIC SHOCK † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
CARDIOPULMONARY FAILURE † 1  2/107 (1.87%)  2 0/51 (0.00%)  0
CORONARY ARTERY DISEASE † 1  2/107 (1.87%)  3 0/51 (0.00%)  0
HYPERTENSIVE HEART DISEASE † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
MYOCARDIAL INFARCTION † 1  1/107 (0.93%)  1 2/51 (3.92%)  2
MYOCARDIAL ISCHAEMIA † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
TACHYCARDIA † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
Congenital, familial and genetic disorders     
ATRIAL SEPTAL DEFECT † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
HYDROCELE † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
Eye disorders     
RETINAL ARTERY OCCLUSION † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
VISION BLURRED † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
Gastrointestinal disorders     
ABDOMINAL PAIN † 1  2/107 (1.87%)  2 1/51 (1.96%)  1
ABDOMINAL PAIN UPPER † 1  2/107 (1.87%)  2 0/51 (0.00%)  0
APHTHOUS ULCER † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
ASCITES † 1  1/107 (0.93%)  1 1/51 (1.96%)  1
DIARRHOEA † 1  0/107 (0.00%)  0 2/51 (3.92%)  2
DYSPHAGIA † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
ENTERITIS † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
GASTRIC ULCER HAEMORRHAGE † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
INGUINAL HERNIA † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
INTESTINAL PSEUDO-OBSTRUCTION † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
NAUSEA † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
SMALL INTESTINAL OBSTRUCTION † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
TOOTH LOSS † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
UMBILICAL HERNIA † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
UPPER GASTROINTESTINAL HAEMORRHAGE † 1  2/107 (1.87%)  2 0/51 (0.00%)  0
VOMITING † 1  1/107 (0.93%)  1 1/51 (1.96%)  1
General disorders     
GAIT DISTURBANCE † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
GENERAL PHYSICAL HEALTH DETERIORATION † 1  4/107 (3.74%)  4 1/51 (1.96%)  1
HYPOTHERMIA † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
IMPAIRED HEALING † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
INFLUENZA LIKE ILLNESS † 1  2/107 (1.87%)  2 0/51 (0.00%)  0
MULTIPLE ORGAN DYSFUNCTION SYNDROME † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
PAIN † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
PERFORMANCE STATUS DECREASED † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
PYREXIA † 1  8/107 (7.48%)  8 0/51 (0.00%)  0
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
Hepatobiliary disorders     
CHOLANGITIS † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
CHOLELITHIASIS † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
HEPATIC FUNCTION ABNORMAL † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
Immune system disorders     
HYPOGAMMAGLOBULINAEMIA † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
Infections and infestations     
ADENOVIRUS INFECTION † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
APPENDICITIS † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
BETA HAEMOLYTIC STREPTOCOCCAL INFECTION † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
BRONCHITIS † 1  2/107 (1.87%)  2 0/51 (0.00%)  0
BRONCHOPULMONARY ASPERGILLOSIS † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
CAMPYLOBACTER INFECTION † 1  1/107 (0.93%)  2 0/51 (0.00%)  0
CELLULITIS † 1  2/107 (1.87%)  2 0/51 (0.00%)  0
CLOSTRIDIUM DIFFICILE COLITIS † 1  1/107 (0.93%)  2 0/51 (0.00%)  0
CLOSTRIDIUM DIFFICILE INFECTION † 1  2/107 (1.87%)  3 0/51 (0.00%)  0
EMPYEMA † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
ERYSIPELAS † 1  1/107 (0.93%)  2 0/51 (0.00%)  0
ESCHERICHIA INFECTION † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
ESCHERICHIA SEPSIS † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
ESCHERICHIA URINARY TRACT INFECTION † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
GASTROENTERITIS SALMONELLA † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
HERPES ZOSTER † 1  3/107 (2.80%)  3 0/51 (0.00%)  0
HERPES ZOSTER CUTANEOUS DISSEMINATED † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
IMPETIGO † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
INFECTED SKIN ULCER † 1  1/107 (0.93%)  2 0/51 (0.00%)  0
INFLUENZA † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
KLEBSIELLA BACTERAEMIA † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
KLEBSIELLA SEPSIS † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
LOWER RESPIRATORY TRACT INFECTION † 1  2/107 (1.87%)  3 2/51 (3.92%)  3
METAPNEUMOVIRUS INFECTION † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
NASOPHARYNGITIS † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
NEUTROPENIC SEPSIS † 1  1/107 (0.93%)  1 1/51 (1.96%)  2
OSTEOMYELITIS † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
PARAINFLUENZAE VIRUS INFECTION † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
PNEUMOCYSTIS JIROVECII INFECTION † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
PNEUMOCYSTIS JIROVECII PNEUMONIA † 1  2/107 (1.87%)  2 0/51 (0.00%)  0
PNEUMONIA † 1  14/107 (13.08%)  15 8/51 (15.69%)  9
PNEUMONIA FUNGAL † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
POST PROCEDURAL INFECTION † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
PSEUDOMONAS INFECTION † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
PULMONARY MYCOSIS † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
PULMONARY SEPSIS † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
RESPIRATORY SYNCYTIAL VIRUS INFECTION † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
RHINOVIRUS INFECTION † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
SCROTAL ABSCESS † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
SCROTAL INFECTION † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
SEPSIS † 1  2/107 (1.87%)  2 1/51 (1.96%)  1
SEPTIC SHOCK † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
SINUSITIS † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
SOFT TISSUE INFECTION † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
STAPHYLOCOCCAL INFECTION † 1  1/107 (0.93%)  1 1/51 (1.96%)  1
UPPER RESPIRATORY TRACT INFECTION † 1  2/107 (1.87%)  2 1/51 (1.96%)  1
URINARY TRACT INFECTION † 1  3/107 (2.80%)  3 0/51 (0.00%)  0
UROSEPSIS † 1  2/107 (1.87%)  2 0/51 (0.00%)  0
VASCULAR DEVICE INFECTION † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
VIRAL INFECTION † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
Injury, poisoning and procedural complications     
ANASTOMOTIC LEAK † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
ANKLE FRACTURE † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
FEMORAL NECK FRACTURE † 1  1/107 (0.93%)  2 0/51 (0.00%)  0
FEMUR FRACTURE † 1  2/107 (1.87%)  2 0/51 (0.00%)  0
FOOT FRACTURE † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
JOINT DISLOCATION † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
MUSCLE STRAIN † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
RADIUS FRACTURE † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
Investigations     
BLOOD CREATININE INCREASED † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
BLOOD GLUCOSE FLUCTUATION † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
CANDIDA TEST POSITIVE † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
ESCHERICHIA TEST POSITIVE † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
PLATELET COUNT DECREASED † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
Metabolism and nutrition disorders     
CACHEXIA † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
DEHYDRATION † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
HYPERCALCAEMIA † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
HYPERKALAEMIA † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
HYPERPHOSPHATAEMIA † 1  1/107 (0.93%)  2 0/51 (0.00%)  0
HYPONATRAEMIA † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
TUMOUR LYSIS SYNDROME † 1  2/107 (1.87%)  2 3/51 (5.88%)  3
Musculoskeletal and connective tissue disorders     
ARTHRALGIA † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
BACK PAIN † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
MUSCULOSKELETAL DISORDER † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
NECK PAIN † 1  1/107 (0.93%)  1 1/51 (1.96%)  1
OSTEOARTHRITIS † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
OSTEONECROSIS † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
ACOUSTIC NEUROMA † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
ACUTE MYELOID LEUKAEMIA † 1  2/107 (1.87%)  2 0/51 (0.00%)  0
ADENOCARCINOMA OF COLON † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
BASAL CELL CARCINOMA † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
BREAST CANCER † 1  2/107 (1.87%)  2 0/51 (0.00%)  0
BRONCHIAL CARCINOMA † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
CENTRAL NERVOUS SYSTEM LYMPHOMA † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
CHRONIC LYMPHOCYTIC LEUKAEMIA † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
COLORECTAL CANCER † 1  1/107 (0.93%)  1 1/51 (1.96%)  1
MALIGNANT MELANOMA † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
MALIGNANT NEOPLASM OF UNKNOWN PRIMARY SITE † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
MALIGNANT NEOPLASM PROGRESSION † 1  18/107 (16.82%)  18 4/51 (7.84%)  4
MYELODYSPLASTIC SYNDROME † 1  2/107 (1.87%)  2 0/51 (0.00%)  0
PLASMA CELL MYELOMA † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
SKIN PAPILLOMA † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
SQUAMOUS CELL CARCINOMA † 1  2/107 (1.87%)  2 0/51 (0.00%)  0
SQUAMOUS CELL CARCINOMA OF SKIN † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
UTERINE CANCER † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
Nervous system disorders     
ATAXIA † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
CEREBRAL INFARCTION † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
DISTURBANCE IN ATTENTION † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
HAEMORRHAGIC STROKE † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
PERIPHERAL SENSORY NEUROPATHY † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
PROGRESSIVE SUPRANUCLEAR PALSY † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
SYNCOPE † 1  3/107 (2.80%)  3 0/51 (0.00%)  0
TRANSIENT ISCHAEMIC ATTACK † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
Psychiatric disorders     
CONFUSIONAL STATE † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
DISORIENTATION † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
SUICIDAL IDEATION † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
Renal and urinary disorders     
ACUTE KIDNEY INJURY † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
BLADDER DISORDER † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
CYSTITIS NONINFECTIVE † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
DYSURIA † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
HAEMATURIA † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
Reproductive system and breast disorders     
VAGINAL PROLAPSE † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
Respiratory, thoracic and mediastinal disorders     
BRONCHITIS CHRONIC † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
CHRONIC OBSTRUCTIVE PULMONARY DISEASE † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
DYSPNOEA † 1  2/107 (1.87%)  2 0/51 (0.00%)  0
DYSPNOEA EXERTIONAL † 1  1/107 (0.93%)  2 0/51 (0.00%)  0
EPISTAXIS † 1  1/107 (0.93%)  3 0/51 (0.00%)  0
PLEURAL EFFUSION † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
PNEUMONIA ASPIRATION † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
PULMONARY EMBOLISM † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
PULMONARY MASS † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
Skin and subcutaneous tissue disorders     
DECUBITUS ULCER † 1  1/107 (0.93%)  2 0/51 (0.00%)  0
ERYTHEMA NODOSUM † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
SKIN HAEMORRHAGE † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
Vascular disorders     
CIRCULATORY COLLAPSE † 1  0/107 (0.00%)  0 1/51 (1.96%)  1
DEEP VEIN THROMBOSIS † 1  2/107 (1.87%)  2 0/51 (0.00%)  0
HYPERTENSIVE CRISIS † 1  1/107 (0.93%)  1 1/51 (1.96%)  1
HYPOTENSION † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE † 1  1/107 (0.93%)  1 0/51 (0.00%)  0
1
Term from vocabulary, MedDRA 23.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Main Cohort Safety Expansion Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   103/107 (96.26%)      50/51 (98.04%)    
Blood and lymphatic system disorders     
ANAEMIA † 1  27/107 (25.23%)  55 11/51 (21.57%)  16
AUTOIMMUNE HAEMOLYTIC ANAEMIA † 1  1/107 (0.93%)  1 3/51 (5.88%)  4
LEUKOPENIA † 1  9/107 (8.41%)  14 2/51 (3.92%)  2
NEUTROPENIA † 1  47/107 (43.93%)  127 22/51 (43.14%)  49
THROMBOCYTOPENIA † 1  24/107 (22.43%)  55 9/51 (17.65%)  20
Ear and labyrinth disorders     
VERTIGO † 1  8/107 (7.48%)  9 2/51 (3.92%)  2
Gastrointestinal disorders     
ABDOMINAL PAIN † 1  8/107 (7.48%)  9 8/51 (15.69%)  9
ABDOMINAL PAIN UPPER † 1  4/107 (3.74%)  5 4/51 (7.84%)  4
CONSTIPATION † 1  11/107 (10.28%)  15 9/51 (17.65%)  10
DIARRHOEA † 1  42/107 (39.25%)  60 26/51 (50.98%)  45
DYSPEPSIA † 1  6/107 (5.61%)  6 3/51 (5.88%)  3
FLATULENCE † 1  4/107 (3.74%)  4 3/51 (5.88%)  4
NAUSEA † 1  35/107 (32.71%)  45 24/51 (47.06%)  32
VOMITING † 1  17/107 (15.89%)  21 2/51 (3.92%)  2
General disorders     
CHILLS † 1  9/107 (8.41%)  9 5/51 (9.80%)  9
FATIGUE † 1  27/107 (25.23%)  32 16/51 (31.37%)  18
OEDEMA PERIPHERAL † 1  12/107 (11.21%)  15 5/51 (9.80%)  5
PAIN † 1  9/107 (8.41%)  10 4/51 (7.84%)  5
PYREXIA † 1  16/107 (14.95%)  22 6/51 (11.76%)  11
Infections and infestations     
BRONCHITIS † 1  13/107 (12.15%)  17 0/51 (0.00%)  0
CONJUNCTIVITIS † 1  6/107 (5.61%)  7 3/51 (5.88%)  5
HERPES ZOSTER † 1  6/107 (5.61%)  7 5/51 (9.80%)  5
INFLUENZA † 1  6/107 (5.61%)  7 3/51 (5.88%)  3
LOWER RESPIRATORY TRACT INFECTION † 1  4/107 (3.74%)  7 4/51 (7.84%)  6
NASOPHARYNGITIS † 1  19/107 (17.76%)  32 8/51 (15.69%)  11
PNEUMONIA † 1  7/107 (6.54%)  8 6/51 (11.76%)  6
RESPIRATORY TRACT INFECTION † 1  11/107 (10.28%)  15 0/51 (0.00%)  0
SINUSITIS † 1  6/107 (5.61%)  7 4/51 (7.84%)  6
SKIN INFECTION † 1  0/107 (0.00%)  0 3/51 (5.88%)  4
TOOTH INFECTION † 1  2/107 (1.87%)  2 3/51 (5.88%)  3
UPPER RESPIRATORY TRACT INFECTION † 1  22/107 (20.56%)  36 15/51 (29.41%)  20
URINARY TRACT INFECTION † 1  12/107 (11.21%)  15 8/51 (15.69%)  14
Injury, poisoning and procedural complications     
ARTHROPOD BITE † 1  1/107 (0.93%)  1 4/51 (7.84%)  4
FALL † 1  7/107 (6.54%)  8 0/51 (0.00%)  0
Investigations     
BLOOD CREATININE INCREASED † 1  8/107 (7.48%)  11 2/51 (3.92%)  3
BLOOD LACTATE DEHYDROGENASE INCREASED † 1  6/107 (5.61%)  6 3/51 (5.88%)  3
NEUTROPHIL COUNT DECREASED † 1  3/107 (2.80%)  6 3/51 (5.88%)  3
PLATELET COUNT DECREASED † 1  3/107 (2.80%)  3 3/51 (5.88%)  5
WEIGHT DECREASED † 1  6/107 (5.61%)  10 0/51 (0.00%)  0
WEIGHT INCREASED † 1  7/107 (6.54%)  9 1/51 (1.96%)  1
Metabolism and nutrition disorders     
DECREASED APPETITE † 1  6/107 (5.61%)  6 1/51 (1.96%)  1
HYPERKALAEMIA † 1  6/107 (5.61%)  9 6/51 (11.76%)  9
HYPERPHOSPHATAEMIA † 1  17/107 (15.89%)  20 3/51 (5.88%)  4
HYPOKALAEMIA † 1  14/107 (13.08%)  25 5/51 (9.80%)  6
HYPOMAGNESAEMIA † 1  3/107 (2.80%)  3 3/51 (5.88%)  5
HYPOPHOSPHATAEMIA † 1  4/107 (3.74%)  7 4/51 (7.84%)  6
Musculoskeletal and connective tissue disorders     
ARTHRALGIA † 1  10/107 (9.35%)  11 9/51 (17.65%)  12
BACK PAIN † 1  13/107 (12.15%)  16 7/51 (13.73%)  8
MUSCLE SPASMS † 1  4/107 (3.74%)  4 5/51 (9.80%)  5
MYALGIA † 1  2/107 (1.87%)  2 9/51 (17.65%)  10
PAIN IN EXTREMITY † 1  6/107 (5.61%)  10 4/51 (7.84%)  5
Nervous system disorders     
DIZZINESS † 1  6/107 (5.61%)  7 7/51 (13.73%)  8
HEADACHE † 1  16/107 (14.95%)  20 12/51 (23.53%)  12
Psychiatric disorders     
INSOMNIA † 1  4/107 (3.74%)  4 4/51 (7.84%)  4
Renal and urinary disorders     
POLLAKIURIA † 1  1/107 (0.93%)  1 3/51 (5.88%)  3
Respiratory, thoracic and mediastinal disorders     
COUGH † 1  16/107 (14.95%)  20 14/51 (27.45%)  19
DYSPNOEA † 1  7/107 (6.54%)  7 7/51 (13.73%)  10
EPISTAXIS † 1  6/107 (5.61%)  9 2/51 (3.92%)  2
NASAL CONGESTION † 1  0/107 (0.00%)  0 3/51 (5.88%)  6
OROPHARYNGEAL PAIN † 1  6/107 (5.61%)  7 3/51 (5.88%)  3
PRODUCTIVE COUGH † 1  2/107 (1.87%)  2 3/51 (5.88%)  4
UPPER-AIRWAY COUGH SYNDROME † 1  1/107 (0.93%)  1 3/51 (5.88%)  3
Skin and subcutaneous tissue disorders     
ALOPECIA † 1  4/107 (3.74%)  4 3/51 (5.88%)  4
DRY SKIN † 1  7/107 (6.54%)  7 4/51 (7.84%)  5
NIGHT SWEATS † 1  3/107 (2.80%)  3 3/51 (5.88%)  3
PRURITUS † 1  7/107 (6.54%)  10 4/51 (7.84%)  4
RASH † 1  11/107 (10.28%)  13 6/51 (11.76%)  6
SKIN LESION † 1  2/107 (1.87%)  3 4/51 (7.84%)  4
Vascular disorders     
HYPERTENSION † 1  15/107 (14.02%)  19 4/51 (7.84%)  4
1
Term from vocabulary, MedDRA 23.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01889186    
Other Study ID Numbers: M13-982
2012-004027-20 ( EudraCT Number )
First Submitted: June 26, 2013
First Posted: June 28, 2013
Results First Submitted: October 6, 2021
Results First Posted: December 16, 2021
Last Update Posted: December 16, 2021