Trial Outcomes & Findings for Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia. (NCT NCT04299048)
NCT ID: NCT04299048
Last Updated: 2023-12-14
Results Overview
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. An AE was considered an TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
11 participants
Primary outcome timeframe
From Day 1 up to Week 24
Results posted on
2023-12-14
Participant Flow
A total of 20 participants were screened for eligibility, of which 11 participants were enrolled into the study. A total of 10 participants were treated.
Participant milestones
| Measure |
PF-06946860 Q3W
During the 12-week treatment period, participants receive a total of 5 subcutaneously (SC) doses of PF-06946860 every 3 weeks (Q3W).
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
Treated
|
10
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
PF-06946860 Q3W
During the 12-week treatment period, participants receive a total of 5 subcutaneously (SC) doses of PF-06946860 every 3 weeks (Q3W).
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Global deterioration of health status
|
2
|
|
Overall Study
Enrolled and not treated
|
1
|
Baseline Characteristics
Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia.
Baseline characteristics by cohort
| Measure |
PF-06946860 Q3W
n=10 Participants
During the 12-week treatment period, participants receive a total of 5 SC doses of PF-06946860 Q3W.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Body Mass Index
|
22.88 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Week 24Population: The safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. An AE was considered an TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs.
Outcome measures
| Measure |
PF-06946860 Q3W
n=10 Participants
During the 12-week treatment period, participants receive a total of 5 SC doses of PF-06946860 Q3W.
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
AEs
|
10 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
SAEs
|
4 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Week 24Population: Overall number of participants analyzed included participants with at least one observation of the given laboratory test while on study treatment or during lag time.
Participants with laboratory test abnormalities (without regard to baseline abnormality) that met pre-specified criteria included Hemoglobin\< 0.8x lower limit of normal (LLN); Hematocrit\< 0.8x LLN; Erythrocytes (Ery.)\< 0.8x LLN; Ery. Mean Corpuscular Volume\< 0.9x LLN; Leukocytes\< 0.6x LLN; Lymphocytes\< 0.8x LLN; Bilirubin\> 1.5x upper limit of normal (ULN); Aspartate Aminotransferase\> 3.0x ULN; Alkaline Phosphatase\> 3.0x ULN; Protein\< 0.8x LLN; Sodium\< 0.95x LLN; Chloride\< 0.9x LLN; Calcium\< 0.9x LLN; Bicarbonate\< 0.9x LLN; Glucose\> 1.5x ULN; C Reactive Protein\> 1.1x ULN; for urinalysis, Urine Glucose ≥1, Ketones ≥1, Urine Protein ≥1, Urine Hemoglobin ≥1, Urobilinogen ≥1, Nitrite ≥1, and Leukocyte ≥1 Esterase ≥1; Hyaline Casts \>1/LPF.
Outcome measures
| Measure |
PF-06946860 Q3W
n=8 Participants
During the 12-week treatment period, participants receive a total of 5 SC doses of PF-06946860 Q3W.
|
|---|---|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Protein (g/dL)< 0.8x LLN
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Ketones ≥1
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
URINE Protein ≥1
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
URINE Hemoglobin ≥1
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Urobilinogen ≥1
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Nitrite ≥1
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Leukocyte Esterase ≥1
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Hyaline Casts >1/LPF
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Hemoglobin (g/dL)< 0.8x LLN
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Hematocrit (%)< 0.8x LLN
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Erythrocytes (10^6/mm^3)< 0.8x LLN
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Ery. Mean Corpuscular Volume (um^3)< 0.9x LLN
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Leukocytes (10^3/mm^3)< 0.6x LLN
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Lymphocytes (10^3/mm^3)< 0.8x LLN
|
3 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Bilirubin (mg/dL)> 1.5x ULN
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Aspartate Aminotransferase (U/L)> 3.0x ULN
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Alkaline Phosphatase (U/L)> 3.0x ULN
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Sodium (mEq/L)< 0.95x LLN
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Chloride (mEq/L)< 0.9x LLN
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Calcium (mg/dL)< 0.9x LLN
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Bicarbonate (mEq/L)< 0.9x LLN
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Glucose (mg/dL)> 1.5x ULN
|
4 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
C Reactive Protein (mg/dL)> 1.1x ULN
|
5 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
URINE Glucose ≥1
|
3 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Week 24Population: Overall number of participants analyzed included participants evaluated against pre-defined criteria for vital signs.
Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the supine position. The pre-specified categorical analysis criteria in vital signs, were supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg), supine SBP increase/decrease from baseline ≥30 mmHg; supine diastolic blood pressure (DBP) \<50 mmHg, supine DBP increase/decrease from baseline ≥20 mmHg; supine pulse rate \<40 beats per minute (bpm) or \>120 bpm.
Outcome measures
| Measure |
PF-06946860 Q3W
n=9 Participants
During the 12-week treatment period, participants receive a total of 5 SC doses of PF-06946860 Q3W.
|
|---|---|
|
Number of Participants With Post-Baseline Vital Signs Abnormalities
Supine SBP - Value <90 mmHg
|
0 Participants
|
|
Number of Participants With Post-Baseline Vital Signs Abnormalities
Supine SBP - Change ≥ 30 mmHg Increase
|
2 Participants
|
|
Number of Participants With Post-Baseline Vital Signs Abnormalities
Supine SBP - Change ≥ 30 mmHg Decrease
|
0 Participants
|
|
Number of Participants With Post-Baseline Vital Signs Abnormalities
Supine DBP - Value <50 mmHg
|
0 Participants
|
|
Number of Participants With Post-Baseline Vital Signs Abnormalities
Supine DBP - Change ≥ 20 mmHg Increase
|
1 Participants
|
|
Number of Participants With Post-Baseline Vital Signs Abnormalities
Supine DBP - Change ≥ 20 mmHg Decrease
|
0 Participants
|
|
Number of Participants With Post-Baseline Vital Signs Abnormalities
Supine Pulse Rate - Value <40 bpm
|
0 Participants
|
|
Number of Participants With Post-Baseline Vital Signs Abnormalities
Supine Pulse Rate - Value >120 bpm
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Week 24Population: Overall number of participants analyzed included participants evaluated against pre-defined criteria for ECGs.
ECG data (PR interval, QRS interval, QT interval, and QTcF) were obtained with participant in the supine position. The pre-specified categorical analysis criteria in ECG, were PR interval: value ≥300 milliseconds (msec), percentage change ≥25/50%; QRS interval: value ≥140 msec, percentage change ≥50%; QT interval: value ≥500 msec; QTcF interval: 470\< value ≤480 msec, 480\< value ≤500 msec, value \>500 msec, and 30\< change ≤60 msec, change \>60 msec.
Outcome measures
| Measure |
PF-06946860 Q3W
n=8 Participants
During the 12-week treatment period, participants receive a total of 5 SC doses of PF-06946860 Q3W.
|
|---|---|
|
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities
Supine QRS Interval - %Chg ≥50%
|
0 Participants
|
|
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities
Supine QTcF - 480<Value≤500 msec
|
0 Participants
|
|
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities
Supine QTcF - Chg>60 msec
|
0 Participants
|
|
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities
Supine PR Interval - Value ≥300 msec
|
0 Participants
|
|
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities
Supine PR Interval - %Chg ≥25/50%
|
0 Participants
|
|
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities
Supine QRS Interval - Value ≥140 msec
|
0 Participants
|
|
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities
Supine QT Interval - Value ≥500 msec
|
0 Participants
|
|
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities
Supine QTcF - 470<Value≤480 msec
|
0 Participants
|
|
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities
Supine QTcF - Value>500 msec
|
0 Participants
|
|
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities
Supine QTcF - 30<Chg≤60 msec
|
2 Participants
|
SECONDARY outcome
Timeframe: Pre-dose at Weeks 3, 6, 9 and 12, and at Week 15Population: The analysis set included all randomized participants who received a dose of PF-06946860 and in whom at least 1 serum concentration value was reported.
Ctrough was defined as the samples measured pre-dose at Weeks 3, 6, 9 and 12, and at Week 15. Serum unbound Ctrough was summarized by time and treatment group.
Outcome measures
| Measure |
PF-06946860 Q3W
n=8 Participants
During the 12-week treatment period, participants receive a total of 5 SC doses of PF-06946860 Q3W.
|
|---|---|
|
Serum Unbound Trough Concentrations (Ctrough) of PF-06946860
Week 3
|
4.041 ng/mL
Geometric Coefficient of Variation 1.28*10^19
|
|
Serum Unbound Trough Concentrations (Ctrough) of PF-06946860
Week 6
|
1690 ng/mL
Geometric Coefficient of Variation 593
|
|
Serum Unbound Trough Concentrations (Ctrough) of PF-06946860
Week 9
|
610.9 ng/mL
Geometric Coefficient of Variation 7.79*10^10
|
|
Serum Unbound Trough Concentrations (Ctrough) of PF-06946860
Week 12
|
4383 ng/mL
Geometric Coefficient of Variation 142
|
|
Serum Unbound Trough Concentrations (Ctrough) of PF-06946860
Week 15
|
560.5 ng/mL
Geometric Coefficient of Variation 2.15*10^12
|
SECONDARY outcome
Timeframe: Pre-dose at Weeks 3, 6, 9 and 12, and at Week 15Population: The analysis set included all randomized participants who received a dose of PF-06946860 and in whom at least 1 serum concentration value was reported.
Ctrough was defined as the samples measured pre-dose at Weeks 3, 6, 9 and 12, and at Week 15. Serum total Ctrough was summarized by time and treatment group.
Outcome measures
| Measure |
PF-06946860 Q3W
n=8 Participants
During the 12-week treatment period, participants receive a total of 5 SC doses of PF-06946860 Q3W.
|
|---|---|
|
Serum Total Ctrough of PF-06946860
Week 9
|
20740 ng/mL
Geometric Coefficient of Variation 24
|
|
Serum Total Ctrough of PF-06946860
Week 12
|
21310 ng/mL
Geometric Coefficient of Variation 32
|
|
Serum Total Ctrough of PF-06946860
Week 15
|
25450 ng/mL
Geometric Coefficient of Variation 31
|
|
Serum Total Ctrough of PF-06946860
Week 3
|
10050 ng/mL
Geometric Coefficient of Variation 19
|
|
Serum Total Ctrough of PF-06946860
Week 6
|
17010 ng/mL
Geometric Coefficient of Variation 16
|
Adverse Events
PF-06946860 Q3W
Serious events: 4 serious events
Other events: 10 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
PF-06946860 Q3W
n=10 participants at risk
During the 12-week treatment period, participants receive a total of 5 SC doses of PF-06946860 Q3W.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Sepsis
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Transaminases increased
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
PF-06946860 Q3W
n=10 participants at risk
During the 12-week treatment period, participants receive a total of 5 SC doses of PF-06946860 Q3W.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
5/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Monocytosis
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Conjunctival hyperaemia
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Lacrimation increased
|
20.0%
2/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
2/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
5/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
4/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Oral pain
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Asthenia
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
40.0%
4/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
COVID-19
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Conjunctivitis
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
2/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Oral contusion
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood bilirubin increased
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Electrocardiogram Q wave abnormal
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Neutrophil count decreased
|
20.0%
2/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Platelet count decreased
|
20.0%
2/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
2/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
2/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Ataxia
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
20.0%
2/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Head discomfort
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Confusional state
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Insomnia
|
20.0%
2/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Dysuria
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Proteinuria
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
10.0%
1/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypertension
|
20.0%
2/10 • From Day 1 up to Week 24
MedDRA 24.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER