Trial Outcomes & Findings for Alvocidib Biomarker-driven Phase 2 AML Study (NCT NCT02520011)
NCT ID: NCT02520011
Last Updated: 2023-11-15
Results Overview
Complete Remission (CR) rate = Percentage of patients achieving CR after Cycle 1 as defined in Stage 1 by the International Working Group (IWG) Criteria and 2010 European LeukemiaNet (EN) criteria in patients with relapsed or refractory AML with MCL-1 dependence \>30% and in Stage 2 by the 2017 ELN criteria. The study was terminated in January 2020 due to a steady and marked reduction in enrollment. Thus, the efficacy endpoints could not be analyzed. As sufficient efficacy results were not available to analyze patients based on the percentage of MCL-1 dependency the treatment efficacy was summarized by distributing the safety population into 6 groups based on whether the patients received the ACM vs CM regimen and their disease stages at study entry.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
104 participants
Primary outcome timeframe
Best response after at least 1 cycle through study completion approximately 4 years
Results posted on
2023-11-15
Participant Flow
Enrolled 104 pts from 14Mar2016 to 12Feb2020 at 22 of 40 sites. Patients were hospitalized until completion of their chemotherapy. The study terminated early in Jan2020 due to a steady and marked reduction in enrollment. The study protocol underwent a few major amendments during the course of the trial. Although the study protocol and the SAP had planned for comprehensive analysis of the efficacy data, only select efficacy analyses could be performed due to early termination of the trial.
Participant milestones
| Measure |
CM Relapsed/Refractory
Patients who were relapsed/refractory AML and were enrolled during Stage 2 and received Cytarabine 2 gm/m2 by continuous infusion over 72 hours on Days 1-3 and Mitoxantrone 40 mg/m2 by IV over 1-2 hours starting 12 hours after completing cytarabine.
|
ACM Relapsed/Refractory
Patients who had relapsed/refractory AML and were enrolled during Stage 1 and Stage 2 and received Alvocidib 30 mg/m2 as a 30-minute intravenous bolus followed by 60 mg/m2 over 4 hours as an IV infusion administered daily on Days 1-3 with Cytarabine 2 gm/m2 by continuous IV infusion on Days 6-8 and Mitoxantrone 40 mg/m2 by IV infusion over 1-2 hours starting 12 hours after completing cytarabine.
|
ACM Newly Diagnosed
Patients who were newly diagnosed AML and enrolled during Stage 1 and Stage 2 and received Alvocidib 30 mg/m2 as a 30-minute intravenous bolus followed by 60 mg/m2 over 4 hours as an IV infusion administered daily on Days 1-3 with Cytarabine 2 gm/m2 by continuous IV infusion on Days 6-8 and Mitoxantrone 40 mg/m2 by IV infusion over 1-2 hours starting 12 hours after completing cytarabine.
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
79
|
14
|
|
Overall Study
Stage 1
|
0
|
32
|
10
|
|
Overall Study
Stage 2
|
11
|
47
|
4
|
|
Overall Study
COMPLETED
|
6
|
33
|
5
|
|
Overall Study
NOT COMPLETED
|
5
|
46
|
9
|
Reasons for withdrawal
| Measure |
CM Relapsed/Refractory
Patients who were relapsed/refractory AML and were enrolled during Stage 2 and received Cytarabine 2 gm/m2 by continuous infusion over 72 hours on Days 1-3 and Mitoxantrone 40 mg/m2 by IV over 1-2 hours starting 12 hours after completing cytarabine.
|
ACM Relapsed/Refractory
Patients who had relapsed/refractory AML and were enrolled during Stage 1 and Stage 2 and received Alvocidib 30 mg/m2 as a 30-minute intravenous bolus followed by 60 mg/m2 over 4 hours as an IV infusion administered daily on Days 1-3 with Cytarabine 2 gm/m2 by continuous IV infusion on Days 6-8 and Mitoxantrone 40 mg/m2 by IV infusion over 1-2 hours starting 12 hours after completing cytarabine.
|
ACM Newly Diagnosed
Patients who were newly diagnosed AML and enrolled during Stage 1 and Stage 2 and received Alvocidib 30 mg/m2 as a 30-minute intravenous bolus followed by 60 mg/m2 over 4 hours as an IV infusion administered daily on Days 1-3 with Cytarabine 2 gm/m2 by continuous IV infusion on Days 6-8 and Mitoxantrone 40 mg/m2 by IV infusion over 1-2 hours starting 12 hours after completing cytarabine.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
2
|
|
Overall Study
Death
|
0
|
8
|
1
|
|
Overall Study
Lack of Efficacy
|
4
|
26
|
4
|
|
Overall Study
Physician Decision
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
0
|
|
Overall Study
Protocol Deviation
|
0
|
1
|
0
|
|
Overall Study
Patient went to hospice
|
0
|
1
|
0
|
|
Overall Study
Progressive disease following response
|
0
|
4
|
2
|
Baseline Characteristics
Alvocidib Biomarker-driven Phase 2 AML Study
Baseline characteristics by cohort
| Measure |
CM Relapsed/Refractory
n=11 Participants
Stage 2 Relapsed/Refractory AML patients who were randomized to receive CM
|
ACM Relapsed/Refractory
n=79 Participants
Relapsed/Refractory AML patients enrolled to Stage 1 and those enrolled to Stage 2 who received ACM.
|
ACM Newly Diagnosed
n=14 Participants
Newly diagnosed AML patients enrolled and received ACM.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
2017 ELN genetic risk criteria classification
Adverse
|
8 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
2017 ELN genetic risk criteria classification
Intermediate
|
1 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
2017 ELN genetic risk criteria classification
Favorable
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
2017 ELN genetic risk criteria classification
Missing
|
0 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Best response after at least 1 cycle through study completion approximately 4 yearsComplete Remission (CR) rate = Percentage of patients achieving CR after Cycle 1 as defined in Stage 1 by the International Working Group (IWG) Criteria and 2010 European LeukemiaNet (EN) criteria in patients with relapsed or refractory AML with MCL-1 dependence \>30% and in Stage 2 by the 2017 ELN criteria. The study was terminated in January 2020 due to a steady and marked reduction in enrollment. Thus, the efficacy endpoints could not be analyzed. As sufficient efficacy results were not available to analyze patients based on the percentage of MCL-1 dependency the treatment efficacy was summarized by distributing the safety population into 6 groups based on whether the patients received the ACM vs CM regimen and their disease stages at study entry.
Outcome measures
| Measure |
Stage 2 CM Relapsed/Refractory
n=11 Participants
Stage 2 Relapsed/Refractory AML patients who were randomized to receive CM
|
Stage 2 ACM Relapsed/Refractory
n=11 Participants
Stage 2 Relapsed/Refractory AML patients who were randomized to receive ACM
|
Stage 1 ACM Relapsed/Refractory
n=25 Participants
Stage 1 Relapsed/Refractory AML patients received ACM
|
Stages 1 and 2 ACM Relapsed/Refractory
n=79 Participants
Stages 1 and 2 Relapsed/Refractory AML patients combined who received ACM
|
Stage 1 Newly Diagnosed ACM
n=14 Participants
Stage 1 Newly Diagnosed AML patients who received ACM
|
All Stages and Cohorts (Including Randomized Stage): ACM Total
n=93 Participants
Total patients who received ACM (Stages 1 and 2 Relapsed/Refractory AML patients and Newly Diagnosed patients combined)"
|
|---|---|---|---|---|---|---|
|
Complete Response (CR) Rate in Patients With Relapsed or Refractory AML
Complete Remission (CR)
|
6 participants
|
2 participants
|
8 participants
|
21 participants
|
6 participants
|
27 participants
|
|
Complete Response (CR) Rate in Patients With Relapsed or Refractory AML
CR with Incomplete Neutrophil Recovery (Cri)
|
0 participants
|
3 participants
|
5 participants
|
15 participants
|
2 participants
|
17 participants
|
|
Complete Response (CR) Rate in Patients With Relapsed or Refractory AML
Partial Remission (PR)
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Complete Response (CR) Rate in Patients With Relapsed or Refractory AML
Resistant/Relapsed Disease
|
5 participants
|
5 participants
|
5 participants
|
30 participants
|
4 participants
|
34 participants
|
|
Complete Response (CR) Rate in Patients With Relapsed or Refractory AML
Not Evaluated
|
0 participants
|
1 participants
|
6 participants
|
12 participants
|
1 participants
|
13 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Best response after at least 1 cycle through study completion approximately 4 yearsPopulation: A total 11 patients were initially randomized to the CM arm. 6 had CR from receiving CM so they did not cross over to receive ACM. Of the remaining 5 patients, only 2 crossed over to receive ACM and were included in the analysis of this outcome.
To determine if treatment with ACM can induce CR in patients with relapsed or refractory AML with MCL-1 dependence of \>30% who failed to achieve CR following 1 cycle of CM
Outcome measures
| Measure |
Stage 2 CM Relapsed/Refractory
n=2 Participants
Stage 2 Relapsed/Refractory AML patients who were randomized to receive CM
|
Stage 2 ACM Relapsed/Refractory
Stage 2 Relapsed/Refractory AML patients who were randomized to receive ACM
|
Stage 1 ACM Relapsed/Refractory
Stage 1 Relapsed/Refractory AML patients received ACM
|
Stages 1 and 2 ACM Relapsed/Refractory
Stages 1 and 2 Relapsed/Refractory AML patients combined who received ACM
|
Stage 1 Newly Diagnosed ACM
Stage 1 Newly Diagnosed AML patients who received ACM
|
All Stages and Cohorts (Including Randomized Stage): ACM Total
Total patients who received ACM (Stages 1 and 2 Relapsed/Refractory AML patients and Newly Diagnosed patients combined)"
|
|---|---|---|---|---|---|---|
|
Response to Treatment
Partial Remission (PR)
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
|
Response to Treatment
Not Evaluated
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
CM Relapsed/Refractory
Serious events: 3 serious events
Other events: 11 other events
Deaths: 1 deaths
ACM Relapsed/Refractory
Serious events: 31 serious events
Other events: 79 other events
Deaths: 11 deaths
ACM Newly Diagnosed
Serious events: 4 serious events
Other events: 14 other events
Deaths: 1 deaths
ACM Total
Serious events: 35 serious events
Other events: 93 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
CM Relapsed/Refractory
n=11 participants at risk
CM Relapse/Refractory patients who received at least 1 dose of study drug
|
ACM Relapsed/Refractory
n=79 participants at risk
ACM Relapsed/Refractory patients who received at least 1 dose of study drug
|
ACM Newly Diagnosed
n=14 participants at risk
ACM Newly Diagnosed patients who received at least 1 dose of study drug
|
ACM Total
n=93 participants at risk
ACM Total patients who received at least 1 dose of study drug
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.5%
2/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.2%
2/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.5%
2/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.2%
2/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
General disorders
Disease progression
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.5%
2/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.2%
2/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
3.8%
3/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
4.3%
4/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Sepsis
|
18.2%
2/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
13.9%
11/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
12.9%
12/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Lung infection
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
3.8%
3/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
4.3%
4/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.5%
2/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.2%
2/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Septic shock
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.5%
2/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.2%
2/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Device related infection
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Enterocolitis viral
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
3.8%
3/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
3.2%
3/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Nervous system disorders
Syncope
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Nervous system disorders
Haemorrhage intracranial
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Psychiatric disorders
Completed suicide
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.5%
2/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.2%
2/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Vascular disorders
Hypotension
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
Other adverse events
| Measure |
CM Relapsed/Refractory
n=11 participants at risk
CM Relapse/Refractory patients who received at least 1 dose of study drug
|
ACM Relapsed/Refractory
n=79 participants at risk
ACM Relapsed/Refractory patients who received at least 1 dose of study drug
|
ACM Newly Diagnosed
n=14 participants at risk
ACM Newly Diagnosed patients who received at least 1 dose of study drug
|
ACM Total
n=93 participants at risk
ACM Total patients who received at least 1 dose of study drug
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
36.4%
4/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
53.2%
42/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
42.9%
6/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
51.6%
48/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Blood and lymphatic system disorders
Anaemia
|
18.2%
2/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
31.6%
25/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.3%
2/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
29.0%
27/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
8.9%
7/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
35.7%
5/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
12.9%
12/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
8.9%
7/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
8.6%
8/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.6%
6/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.3%
2/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
8.6%
8/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
21.4%
3/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
4.3%
4/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Blood and lymphatic system disorders
Splenic haematoma
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Cardiac disorders
Sinus tachycardia
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
11.4%
9/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
28.6%
4/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.0%
13/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
8.9%
7/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.3%
2/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
9.7%
9/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
3.8%
3/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.3%
2/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.4%
5/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.1%
4/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
4.3%
4/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.3%
2/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.2%
2/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Eye disorders
Dry eye
|
18.2%
2/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.5%
2/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.2%
2/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Eye disorders
Mydriasis
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Eye disorders
Ocular discomfort
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
54.5%
6/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
83.5%
66/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
78.6%
11/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
82.8%
77/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Nausea
|
72.7%
8/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
55.7%
44/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
64.3%
9/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
57.0%
53/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
2/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
39.2%
31/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
50.0%
7/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
40.9%
38/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
27.8%
22/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
42.9%
6/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
30.1%
28/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Constipation
|
36.4%
4/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
20.3%
16/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
35.7%
5/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
22.6%
21/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
17.7%
14/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
21.4%
3/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
18.3%
17/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Dry mouth
|
18.2%
2/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
12.7%
10/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
11.8%
11/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Haemorrhoids
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.3%
5/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
21.4%
3/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
8.6%
8/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Abdominal distension
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
8.9%
7/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.5%
7/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.6%
6/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.5%
7/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Colitis
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.1%
4/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.3%
2/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.5%
6/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Proctalgia
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.3%
5/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.5%
6/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.3%
5/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.4%
5/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.1%
4/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.4%
5/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.1%
4/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
4.3%
4/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.5%
2/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.3%
2/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
4.3%
4/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Oral disorder
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
3.8%
3/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
3.2%
3/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.2%
2/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Gingival bleeding
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.5%
2/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.2%
2/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Salivary gland disorder
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Gastrointestinal disorders
Odynophagia
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
General disorders
Oedema peripheral
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
36.7%
29/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
50.0%
7/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
38.7%
36/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
General disorders
Pyrexia
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
39.2%
31/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
35.7%
5/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
38.7%
36/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
General disorders
Fatigue
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
36.7%
29/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
35.7%
5/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
36.6%
34/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
General disorders
Chills
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
12.7%
10/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
28.6%
4/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
15.1%
14/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
General disorders
Mucosal inflammation
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
11.4%
9/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
9.7%
9/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
General disorders
Chest pain
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.3%
5/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.4%
5/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
General disorders
Malaise
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
3.8%
3/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
4.3%
4/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
General disorders
Non-cardiac chest pain
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.1%
4/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
4.3%
4/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
General disorders
Oedema
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.1%
4/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
4.3%
4/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
General disorders
Pain
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.1%
4/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
4.3%
4/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
General disorders
Face oedema
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.5%
2/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
3.2%
3/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
General disorders
Disease progression
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.5%
2/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.2%
2/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
General disorders
Generalised oedema
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.2%
2/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
General disorders
Facial pain
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
General disorders
Asthenia
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.1%
4/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.4%
5/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.1%
4/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.4%
5/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Immune system disorders
Graft versus host disease
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Sepsis
|
18.2%
2/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
16.5%
13/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
21.4%
3/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
17.2%
16/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Lung infection
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.6%
6/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
21.4%
3/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
8.6%
8/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Pneumonia
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.6%
6/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.3%
2/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
8.6%
8/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Device related infection
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.3%
5/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.5%
6/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.6%
6/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.5%
6/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.3%
5/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.4%
5/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.3%
5/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.4%
5/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.3%
5/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.4%
5/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.1%
4/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
4.3%
4/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.1%
4/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
4.3%
4/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.1%
4/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
4.3%
4/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Oral herpes
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
3.8%
3/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
4.3%
4/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.3%
2/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
3.2%
3/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Urinary tract infection
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.5%
2/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.2%
2/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Cystitis
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Cytomegalovirus infection
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Bronchiolitis
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Groin abscess
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Herpes virus infection
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Hordeolum
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
10.1%
8/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
35.7%
5/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.0%
13/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.6%
6/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.5%
7/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.3%
5/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.3%
2/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.5%
7/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.1%
4/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
4.3%
4/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.5%
2/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
3.2%
3/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Investigations
White blood cell count decreased
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
34.2%
27/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
28.6%
4/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
33.3%
31/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Investigations
Alanine aminotransferase increased
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
24.1%
19/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
28.6%
4/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
24.7%
23/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Investigations
Platelet count decreased
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
22.8%
18/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
28.6%
4/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
23.7%
22/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Investigations
Aspartate aminotransferase increased
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
24.1%
19/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.3%
2/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
22.6%
21/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Investigations
Lymphocyte count decreased
|
18.2%
2/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
16.5%
13/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
28.6%
4/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
18.3%
17/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
15.2%
12/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.0%
13/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Investigations
Weight decreased
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
10.1%
8/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
21.4%
3/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
11.8%
11/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Investigations
Blood bilirubin increased
|
18.2%
2/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.6%
6/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
21.4%
3/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
9.7%
9/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.6%
6/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.5%
6/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.6%
6/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.5%
6/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.1%
4/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.4%
5/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.1%
4/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.4%
5/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.1%
4/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.4%
5/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.1%
4/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
4.3%
4/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.2%
2/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
50.6%
40/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
50.0%
7/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
50.5%
47/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
18.2%
2/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
35.4%
28/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
35.7%
5/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
35.5%
33/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
26.6%
21/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
21.4%
3/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
25.8%
24/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
25.3%
20/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
28.6%
4/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
25.8%
24/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
17.7%
14/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
57.1%
8/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
23.7%
22/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
22.8%
18/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
21.4%
3/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
22.6%
21/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
16.5%
13/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
28.6%
4/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
18.3%
17/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
15.2%
12/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
21.4%
3/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
16.1%
15/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
11.4%
9/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
9.7%
9/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
8.9%
7/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
8.6%
8/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.3%
5/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.3%
2/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.5%
7/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Metabolism and nutrition disorders
Fluid overload
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.6%
6/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.5%
6/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.2%
2/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
19.0%
15/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
17.2%
16/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.3%
5/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.5%
6/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.3%
5/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.5%
6/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
3.8%
3/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
3.2%
3/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.2%
2/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
3.8%
3/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
3.2%
3/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.2%
2/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Nervous system disorders
Headache
|
18.2%
2/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
26.6%
21/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.3%
2/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
24.7%
23/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Nervous system disorders
Dysgeusia
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
10.1%
8/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
21.4%
3/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
11.8%
11/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
10.1%
8/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.3%
2/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
10.8%
10/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Nervous system disorders
Syncope
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
3.8%
3/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
4.3%
4/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.2%
2/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Nervous system disorders
Cerebrovascular accident
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Nervous system disorders
Haemorrhage intracranial
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
17.7%
14/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
21.4%
3/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
18.3%
17/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.6%
6/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.3%
2/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
8.6%
8/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.6%
6/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.5%
6/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Psychiatric disorders
Hallucination
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Psychiatric disorders
Completed suicide
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
13.9%
11/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.3%
2/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.0%
13/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.6%
6/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.5%
6/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.5%
2/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
3.2%
3/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.2%
2/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.5%
2/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.2%
2/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Reproductive system and breast disorders
Acquired phimosis
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
20.3%
16/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.3%
2/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
19.4%
18/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
12.7%
10/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
21.4%
3/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.0%
13/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
12.7%
10/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
11.8%
11/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.3%
5/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.3%
2/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.5%
7/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.6%
6/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.5%
7/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.1%
4/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.3%
2/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.5%
6/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.1%
4/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.4%
5/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
3.8%
3/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
4.3%
4/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.2%
2/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.2%
2/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.2%
2/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
12.7%
10/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
35.7%
5/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
16.1%
15/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
16.5%
13/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
15.1%
14/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
11.4%
9/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
14.3%
2/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
11.8%
11/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.3%
5/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.5%
6/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.6%
6/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
6.5%
6/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
3.8%
3/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
4.3%
4/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.1%
4/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
4.3%
4/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.5%
2/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
3.2%
3/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.5%
2/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
3.2%
3/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.5%
2/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
3.2%
3/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.2%
2/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
9.1%
1/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Vascular disorders
Hypotension
|
18.2%
2/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
21.5%
17/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
35.7%
5/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
23.7%
22/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Vascular disorders
Hypertension
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
11.4%
9/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
9.7%
9/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.1%
4/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
5.4%
5/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Vascular disorders
Hot flush
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.3%
1/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
2.2%
2/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
|
Vascular disorders
Embolism
|
0.00%
0/11 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
0.00%
0/79 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
7.1%
1/14 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
1.1%
1/93 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.
|
Additional Information
Susan Smith
Sumitomo Dainippon Pharma Oncology, Inc.
Phone: +1-210-414-7702
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place