Trial Outcomes & Findings for Acalabrutinib Study in Indian Patients With Chronic Lymphocytic Leukaemia & Relapsed and Refractory Mantle Cell Lymphoma (NCT NCT04930536)
NCT ID: NCT04930536
Last Updated: 2024-11-22
Results Overview
The AESIs for acalabrutinib, including arrhythmias (atrial fibrillation), anaemia, hypertension, bleeding, and infections, are presented.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
103 participants
Primary outcome timeframe
Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
Results posted on
2024-11-22
Participant Flow
103 participants were consented and were divided into two groups, participants with CLL/SLL (N=90) and participants with MCL (N=13). Out of these, 100 participants (89 in the CLL/SLL and 11 in the MCL group) were considered in the full analysis set, 03 enrolled participants were discontinued due to withdrawal of the consent form.
Participant milestones
| Measure |
CCL/SLL
Participants were treatment naïve or had received at least one prior therapy
|
Relapsed and Refractory MCL
Participants had received at least one prior therapy
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
13
|
|
Overall Study
COMPLETED
|
82
|
8
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
| Measure |
CCL/SLL
Participants were treatment naïve or had received at least one prior therapy
|
Relapsed and Refractory MCL
Participants had received at least one prior therapy
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Disease Progression
|
2
|
0
|
|
Overall Study
Patient Decision
|
4
|
2
|
|
Overall Study
Death, Serious Adverse Event, Screen Failure
|
1
|
3
|
Baseline Characteristics
Acalabrutinib Study in Indian Patients With Chronic Lymphocytic Leukaemia & Relapsed and Refractory Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
CCL/SLL
n=89 Participants
Participants were treatment naïve or had received at least one prior therapy
|
Relapsed and Refractory MCL
n=11 Participants
Participants had received at least one prior therapy
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.8 Years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
60.3 Years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
61.6 Years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
89 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
100 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])Population: Safety Analysis Set
The AESIs for acalabrutinib, including arrhythmias (atrial fibrillation), anaemia, hypertension, bleeding, and infections, are presented.
Outcome measures
| Measure |
CLL/SLL
n=89 Participants
Participants were treatment naïve or had received at least one prior therapy
|
Relapsed and Refractory MCL
n=11 Participants
Participants had received at least one prior therapy
|
|---|---|---|
|
Adverse Events of Special Interest (AESI) Including Arrhythmias (Atrial Fibrillation), Anaemia, Hypertension, Bleeding, Infections
|
0 Events
|
0 Events
|
PRIMARY outcome
Timeframe: Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])Population: Safety Analysis Set
The safety of acalabrutinib was investigated by determining the number of second primary malignancies.
Outcome measures
| Measure |
CLL/SLL
n=89 Participants
Participants were treatment naïve or had received at least one prior therapy
|
Relapsed and Refractory MCL
n=11 Participants
Participants had received at least one prior therapy
|
|---|---|---|
|
Second Primary Malignancies
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Visit 5 (Day 85) and Visit 8 (Day 170)Population: Full Analysis Set
The efficacy of acalabrutinib was assessed by measuring the participants' objective response to treatment. Objective response = Complete Response (CR) + Partial Response (PR) + Partial Response with lymphocytosis (PRL).
Outcome measures
| Measure |
CLL/SLL
n=89 Participants
Participants were treatment naïve or had received at least one prior therapy
|
Relapsed and Refractory MCL
n=11 Participants
Participants had received at least one prior therapy
|
|---|---|---|
|
Objective Response to Treatment
Visit 5: CR
|
1 Participants
|
2 Participants
|
|
Objective Response to Treatment
Visit 5: PR
|
53 Participants
|
3 Participants
|
|
Objective Response to Treatment
Visit 5: PRL
|
1 Participants
|
0 Participants
|
|
Objective Response to Treatment
Visit 5: Objective Response
|
55 Participants
|
5 Participants
|
|
Objective Response to Treatment
Visit 8: CR
|
4 Participants
|
0 Participants
|
|
Objective Response to Treatment
Visit 8: PR
|
50 Participants
|
4 Participants
|
|
Objective Response to Treatment
Visit 8: PRL
|
1 Participants
|
0 Participants
|
|
Objective Response to Treatment
Visit 8: Objective Response
|
55 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From Visit 1 (Day 0), during Visit 5 (Day 85), and at Visit 8 (Day 170)Population: Full Analysis Set
The EORTC QLQ-C30 is a 30-item questionnaire that measures quality of life in cancer patients. It is divided into several scales: Functioning Scales (Physical, Role, Cognitive, Emotional, and Social), Symptom Scales (Fatigue, Pain, Nausea/Vomiting), Dyspnoea, Sleep Disturbances, Appetite Loss, Diarrhoea, Constipation, Financial Difficulties, and Global Health Status/Quality of Life Scale. Scores range from 0 to 100. A higher score indicates better health related quality of life. The total scores were calculated from the mean of the 13 QLQ-C30 scales (Global Quality of Life Scale and Financial Impact Scale were excluded). Prior to calculating the mean, Symptom Scales were reversed to obtain a uniform direction of all scales. The total score was only calculated if all of the required 13 scale scores were available using scale scores based on the completed items, provided that at least 50% of the items in that scale were completed.
Outcome measures
| Measure |
CLL/SLL
n=89 Participants
Participants were treatment naïve or had received at least one prior therapy
|
Relapsed and Refractory MCL
n=11 Participants
Participants had received at least one prior therapy
|
|---|---|---|
|
Health Related Quality of Life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [EORTC QLQC30] Questionnaire)
Visit 1 Total Score
|
56.9 Score on a scale
Standard Deviation 12.52
|
57.0 Score on a scale
Standard Deviation 6.46
|
|
Health Related Quality of Life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [EORTC QLQC30] Questionnaire)
Visit 5 Total Score
|
56.8 Score on a scale
Standard Deviation 7.88
|
57.9 Score on a scale
Standard Deviation 7.21
|
|
Health Related Quality of Life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [EORTC QLQC30] Questionnaire)
Visit 8 Total Score
|
57.9 Score on a scale
Standard Deviation 9.34
|
58.6 Score on a scale
Standard Deviation 6.76
|
Adverse Events
CCL/SLL
Serious events: 8 serious events
Other events: 38 other events
Deaths: 1 deaths
Relapsed and Refractory MCL
Serious events: 3 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
CCL/SLL
n=89 participants at risk
Participants were treatment naïve or had received at least one prior therapy
|
Relapsed and Refractory MCL
n=11 participants at risk
Participants had received at least one prior therapy
|
|---|---|---|
|
General disorders
Pyrexia
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Infections and infestations
Covid-19 pneumonia
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/89 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
9.1%
1/11 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Infections and infestations
Pneumonia
|
3.4%
3/89 • Number of events 3 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/89 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
9.1%
1/11 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/89 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
9.1%
1/11 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Cardiac disorders
Myocardial infarction
|
2.2%
2/89 • Number of events 2 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
Other adverse events
| Measure |
CCL/SLL
n=89 participants at risk
Participants were treatment naïve or had received at least one prior therapy
|
Relapsed and Refractory MCL
n=11 participants at risk
Participants had received at least one prior therapy
|
|---|---|---|
|
Ear and labyrinth disorders
Deafness
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Eye disorders
Cataract
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
9.1%
1/11 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Gastrointestinal disorders
Constipation
|
4.5%
4/89 • Number of events 4 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Gastrointestinal disorders
Diarrhoea
|
9.0%
8/89 • Number of events 10 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
9.1%
1/11 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Gastrointestinal disorders
Gastritis
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Gastrointestinal disorders
Nausea
|
2.2%
2/89 • Number of events 2 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Blood and lymphatic system disorders
Anaemia
|
4.5%
4/89 • Number of events 5 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
9.1%
1/11 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Gastrointestinal disorders
Stomatitis
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
General disorders
Asthenia
|
1.1%
1/89 • Number of events 2 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
General disorders
Face oedema
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
General disorders
Fatigue
|
2.2%
2/89 • Number of events 2 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
General disorders
Inflammation
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
General disorders
Malaise
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
General disorders
Oedema peripheral
|
3.4%
3/89 • Number of events 3 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
General disorders
Peripheral swelling
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
General disorders
Pyrexia
|
9.0%
8/89 • Number of events 10 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Immune system disorders
Hypersensitivity
|
2.2%
2/89 • Number of events 2 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.2%
2/89 • Number of events 2 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Infections and infestations
Abdominal infection
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Infections and infestations
Bacterial infection
|
2.2%
2/89 • Number of events 2 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Infections and infestations
Covid-19 pneumonia
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/89 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
9.1%
1/11 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Infections and infestations
Dengue fever
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Infections and infestations
Fungal infection
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Infections and infestations
Furuncle
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Infections and infestations
Gastrointestinal infection
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Infections and infestations
Oral herpes
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Infections and infestations
Pneumonia
|
2.2%
2/89 • Number of events 2 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Infections and infestations
Respiratory tract infection viral
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Infections and infestations
Rhinitis
|
0.00%
0/89 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
9.1%
1/11 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Infections and infestations
Skin infection
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
9.1%
1/11 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Infections and infestations
Urinary tract infection
|
2.2%
2/89 • Number of events 2 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.2%
2/89 • Number of events 2 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Injury, poisoning and procedural complications
Contusion
|
1.1%
1/89 • Number of events 3 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/89 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
9.1%
1/11 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Investigations
Blood glucose increased
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Investigations
Lipase
|
1.1%
1/89 • Number of events 2 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Investigations
Platelet count decreased
|
0.00%
0/89 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
9.1%
1/11 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Investigations
Sars-cov-2 test positive
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Metabolism and nutrition disorders
Iron deficiency
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
2/89 • Number of events 2 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
2/89 • Number of events 2 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
9.1%
1/11 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/89 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
9.1%
1/11 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Nervous system disorders
Headache
|
3.4%
3/89 • Number of events 3 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Psychiatric disorders
Insomnia
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Renal and urinary disorders
Dysuria
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Renal and urinary disorders
Haematuria
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
5/89 • Number of events 5 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
9.1%
1/11 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
9.1%
1/11 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
9.1%
1/11 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Cardiac disorders
Angina pectoris
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.2%
2/89 • Number of events 3 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.2%
2/89 • Number of events 2 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Vascular disorders
Hypertension
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Vascular disorders
Hypotension
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Vascular disorders
Pallor
|
1.1%
1/89 • Number of events 2 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Cardiac disorders
Conduction disorder
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Vascular disorders
Thrombosis
|
1.1%
1/89 • Number of events 1 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
|
Cardiac disorders
Myocardial infarction
|
2.2%
2/89 • Number of events 2 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
0.00%
0/11 • Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator shall be entitled to publish the results of, or make presentations related to, the Study, provided that any publications or presentations to be made within 2 years after completion of the Study shall require the Sponsor's prior written consent.
- Publication restrictions are in place
Restriction type: OTHER