Trial Outcomes & Findings for Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia (NCT NCT04803305)

Last Updated: 2024-01-12

Results Overview

The Cancer-Related Cachexia Symptom Assessment-Appetite was a self-reported questionnaire that measured the severity of anorexia. The measure consisted of 1 question that asked study participants to rate their appetite over the past 7 days from 0-"no appetite" to 10-"very good appetite", where higher score indicated better appetite. In this Outcome Measure (OM), changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Appetite score at Week 4 were summarized descriptively by treatment group.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

Baseline, Week 4

Results posted on

2024-01-12

Participant Flow

A total of 18 participants were enrolled into the study and treated.

Participant milestones

Participant milestones
Measure	Placebo -> OL PF-06946860 200mg Q3W Participants received placebo during the 6-week double-blind phase (Part A) 3 weeks apart (Q3W) subcutaneously (SC). Starting at the Week 6 visit, participants who continued to the optional open-label treatment (OLT) period of up to 18 weeks (Part B) had an opportunity to receive up to 7 additional doses of PF-06946860 200 mg Q3W. Each dose was comprised of two 1 mL SC injections which were administered consecutively.	PF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W Participants received PF-06946860 200 mg during the 6-week double-blind phase (Part A) Q3W SC. Starting at the Week 6 visit, participants who continued to the optional OLT period of up to 18 weeks (Part B) had an opportunity to receive up to 7 additional doses of PF-06946860 200 mg Q3W. Each dose was comprised of two 1 mL SC injections which were administered consecutively.
Part A: 6-week Double-blind Treatment STARTED	6	12
Part A: 6-week Double-blind Treatment COMPLETED	5	9
Part A: 6-week Double-blind Treatment NOT COMPLETED	1	3
Part B: OLT Period up to 18 Weeks STARTED	5	9
Part B: OLT Period up to 18 Weeks COMPLETED	2	5
Part B: OLT Period up to 18 Weeks NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo -> OL PF-06946860 200mg Q3W Participants received placebo during the 6-week double-blind phase (Part A) 3 weeks apart (Q3W) subcutaneously (SC). Starting at the Week 6 visit, participants who continued to the optional open-label treatment (OLT) period of up to 18 weeks (Part B) had an opportunity to receive up to 7 additional doses of PF-06946860 200 mg Q3W. Each dose was comprised of two 1 mL SC injections which were administered consecutively.	PF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W Participants received PF-06946860 200 mg during the 6-week double-blind phase (Part A) Q3W SC. Starting at the Week 6 visit, participants who continued to the optional OLT period of up to 18 weeks (Part B) had an opportunity to receive up to 7 additional doses of PF-06946860 200 mg Q3W. Each dose was comprised of two 1 mL SC injections which were administered consecutively.
Part A: 6-week Double-blind Treatment Death	0	2
Part A: 6-week Double-blind Treatment Withdrawal by Subject	0	1
Part A: 6-week Double-blind Treatment Physician Decision	1	0
Part B: OLT Period up to 18 Weeks Other	0	1
Part B: OLT Period up to 18 Weeks Withdrawal by Subject	1	0
Part B: OLT Period up to 18 Weeks Physician Decision	0	1
Part B: OLT Period up to 18 Weeks Death	1	2
Part B: OLT Period up to 18 Weeks Adverse Event	1	0

Baseline Characteristics

Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo -> OL PF-06946860 200mg Q3W n=6 Participants Participants received placebo during the 6-week double-blind phase (Part A) Q3W SC. Starting at the Week 6 visit, participants who continued to the optional OLT period of up to 18 weeks (Part B) had an opportunity to receive up to 7 additional doses of PF-06946860 200 mg Q3W. Each dose was comprised of two 1 mL SC injections which were administered consecutively.	PF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W n=12 Participants Participants received PF-06946860 200 mg during the 6-week double-blind phase (Part A) Q3W SC. Starting at the Week 6 visit, participants who continued to the optional OLT period of up to 18 weeks (Part B) had an opportunity to receive up to 7 additional doses of PF-06946860 200 mg Q3W. Each dose was comprised of two 1 mL SC injections which were administered consecutively.	Total n=18 Participants Total of all reporting groups
Age, Continuous	68.0 Years STANDARD_DEVIATION 7.95 • n=5 Participants	74.0 Years STANDARD_DEVIATION 9.12 • n=7 Participants	72.0 Years STANDARD_DEVIATION 8.99 • n=5 Participants
Age, Customized <18	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized 18-44	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized 45-64	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Customized >=65	4 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	3 Participants n=5 Participants	11 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 4

Population: The analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. The number analyzed in each group was the number of participants with non-missing data in the analysis set at a given visit. Number of participants analyzed/number analyzed = number of participants evaluable for this OM in each treatment group.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received placebo during the 6-week double-blind phase (Part A) Q3W SC.	PF-06946860 200mg Q3W n=9 Participants Participants received PF-06946860 200 mg during the 6-week double-blind phase (Part A) Q3W SC.
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A	2.45 Units on a Scale Interval 1.01 to 3.88	1.84 Units on a Scale Interval 0.79 to 2.9

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 3, 5 and 6

Population: The analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. The number analyzed at each timepoint in each group was the number of participants with non-missing data in the analysis set at a given visit. Number of participants analyzed = number of participants evaluable for this OM, number analyzed = number of participants evaluable at each timepoint for each treatment group.

The Cancer-Related Cachexia Symptom Assessment-Appetite was a self-reported questionnaire that measured the severity of anorexia. The measure consisted of 1 question that asked study participants to rate their appetite over the past 7 days from 0-"no appetite" to 10-"very good appetite", where higher score indicated better appetite. In this OM, changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Appetite score were summarized descriptively by treatment group and timepoint.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants received placebo during the 6-week double-blind phase (Part A) Q3W SC.	PF-06946860 200mg Q3W n=12 Participants Participants received PF-06946860 200 mg during the 6-week double-blind phase (Part A) Q3W SC.
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A Week 1	0.99 Units on a Scale Interval -0.66 to 2.64	2.19 Units on a Scale Interval 1.17 to 3.2
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A Week 2	1.11 Units on a Scale Interval -0.03 to 2.25	2.21 Units on a Scale Interval 1.45 to 2.98
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A Week 3	1.27 Units on a Scale Interval -0.35 to 2.89	2.30 Units on a Scale Interval 1.2 to 3.41
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A Week 5	1.95 Units on a Scale Interval 0.27 to 3.63	1.95 Units on a Scale Interval 0.82 to 3.08
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A Week 6	2.41 Units on a Scale Interval 0.49 to 4.33	1.61 Units on a Scale Interval 0.32 to 2.9

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 3, 4, 5 and 6

The Cancer-Related Cachexia Symptom Assessment-Fatigue was a self-reported questionnaire that measured the severity of fatigue. The measure consisted of 1 question that asked study participants to rate their fatigue over the past 7 days from 0-"no fatigue" to 10-"worst possible fatigue", where higher score indicated worse fatigue. In this OM, changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Fatigue score were summarized descriptively by treatment group and timepoint.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants received placebo during the 6-week double-blind phase (Part A) Q3W SC.	PF-06946860 200mg Q3W n=12 Participants Participants received PF-06946860 200 mg during the 6-week double-blind phase (Part A) Q3W SC.
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A Week 1	1.84 Units on a Scale Interval -1.47 to 5.16	1.52 Units on a Scale Interval -0.57 to 3.6
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A Week 2	0.04 Units on a Scale Interval -2.71 to 2.8	-2.12 Units on a Scale Interval -3.91 to -0.34
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A Week 3	-1.21 Units on a Scale Interval -2.33 to -0.09	-0.49 Units on a Scale Interval -1.23 to 0.25
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A Week 4	-1.00 Units on a Scale Interval -2.4 to 0.4	-0.55 Units on a Scale Interval -1.57 to 0.48
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A Week 5	-0.92 Units on a Scale Interval -2.47 to 0.63	-0.24 Units on a Scale Interval -1.31 to 0.82
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A Week 6	-1.13 Units on a Scale Interval -2.4 to 0.15	0.74 Units on a Scale Interval -0.09 to 1.57

SECONDARY outcome

Timeframe: Day 1 through Week 6 (for a period of 6 weeks)

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs are events between first dose of study drug and up to discharge from study that are absent before treatment or that worsen relative to pretreatment state. An SAE is any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants received placebo during the 6-week double-blind phase (Part A) Q3W SC.	PF-06946860 200mg Q3W n=12 Participants Participants received PF-06946860 200 mg during the 6-week double-blind phase (Part A) Q3W SC.
Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part A Participants With All-Causality TEAEs	4 Participants	7 Participants
Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part A Participants With All-Causality SAEs	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Days 1, 22 and 43

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention, with at least one observation of the given laboratory test while on study treatment or during lag time.

Laboratory parameters included: hematology (hemoglobin, hematocrit, erythrocytes, erythrocytes mean corpuscular volume, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular hemoglobin concentration, platelets, leukocytes, lymphocytes, basophils, eosinophils and monocytes), chemistry (bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate and glucose) and urine (pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, leukocyte esterase, urine erythrocytes \[/high power field (HPF)\], urine leukocytes \[/HPF\] and hyaline casts \[/low power field (LPF)\]).

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received placebo during the 6-week double-blind phase (Part A) Q3W SC.	PF-06946860 200mg Q3W n=11 Participants Participants received PF-06946860 200 mg during the 6-week double-blind phase (Part A) Q3W SC.
Number of Participants With Laboratory Test Abnormalities in Part A Erythrocytes Mean Corpuscular Volume >1.1 x upper limit of normal (ULN)	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Erythrocytes Mean Corpuscular Hemoglobin <0.9 x LLN	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Erythrocytes Mean Corpuscular Hemoglobin Concentration <0.9 x LLN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Urate >1.2 x ULN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Leukocyte Esterase >=1	1 Participants	2 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Hemoglobin <0.8 x lower limit of normal (LLN)	2 Participants	4 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Hematocrit <0.8 x LLN	2 Participants	3 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Erythrocytes <0.8 x LLN	1 Participants	4 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Erythrocytes Mean Corpuscular Volume <0.9 x LLN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Erythrocytes Mean Corpuscular Hemoglobin >1.1 x ULN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Erythrocytes Mean Corpuscular Hemoglobin Concentration >1.1 x ULN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Platelets <0.5 x LLN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Platelets >1.75 x ULN	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Leukocytes <0.6 x LLN	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Leukocytes >1.5 x ULN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Lymphocytes <0.8 x LLN	2 Participants	6 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Lymphocytes >1.2 x ULN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Basophils >1.2 x ULN	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Eosinophils >1.2 x ULN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Monocytes >1.2 x ULN	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Bilirubin >1.5 x ULN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Aspartate Aminotransferase >3.0 x ULN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Alanine Aminotransferase >3.0 x ULN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Alkaline Phosphatase >3.0 x ULN	0 Participants	2 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Protein <0.8 x LLN	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Protein >1.2 x ULN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Albumin <0.8 x LLN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Albumin >1.2 x ULN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Blood Urea Nitrogen >1.3 x ULN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Creatinine >1.3 x ULN	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Sodium <0.95 x LLN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Sodium >1.05 x ULN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Potassium <0.9 x LLN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Potassium >1.1 x ULN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Chloride <0.9 x LLN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Chloride >1.1 x ULN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Calcium <0.9 x LLN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Calcium >1.1 x ULN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Bicarbonate <0.9 x LLN	1 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Bicarbonate >1.1 x ULN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Glucose <0.6 x LLN	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Glucose >1.5 x ULN	1 Participants	2 Participants
Number of Participants With Laboratory Test Abnormalities in Part A pH <4.5	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A pH >8	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Urine Glucose >=1	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Ketones >=1	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Urine Protein >=1	2 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Urine Hemoglobin >=1	0 Participants	2 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Urobilinogen >=1	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Urine Bilirubin >=1	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Nitrite >=1	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Urine Erythrocytes (/HPF) >=20	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Urine Leukocytes (/HPF) >=20	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities in Part A Hyaline Casts (/LPF) >1	0 Participants	2 Participants

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

PF-06946860 200mg Q3W

Serious events: 3 serious events

Other events: 4 other events

Deaths: 2 deaths

Placebo -> OL PF-06946860 200mg Q3W

Serious events: 2 serious events

Other events: 6 other events

Deaths: 2 deaths

PF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W

Serious events: 5 serious events

Other events: 8 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=6 participants at risk Participants received placebo during the 6-week double-blind phase (Part A) Q3W SC.	PF-06946860 200mg Q3W n=12 participants at risk Participants received PF-06946860 200 mg during the 6-week double-blind phase (Part A) Q3W SC.	Placebo -> OL PF-06946860 200mg Q3W n=6 participants at risk Participants received placebo during the 6-week double-blind phase (Part A) Q3W SC. Starting at the Week 6 visit, participants who continued to the optional OLT period of up to 18 weeks (Part B) had an opportunity to receive up to 7 additional doses of PF-06946860 200 mg Q3W. Each dose was comprised of two 1 mL SC injections which were administered consecutively.	PF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W n=12 participants at risk Participants received PF-06946860 200 mg during the 6-week double-blind phase (Part A) Q3W SC. Starting at the Week 6 visit, participants who continued to the optional OLT period of up to 18 weeks (Part B) had an opportunity to receive up to 7 additional doses of PF-06946860 200 mg Q3W. Each dose was comprised of two 1 mL SC injections which were administered consecutively.
Cardiac disorders Acute myocardial infarction	0.00% 0/6 • Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.	8.3% 1/12 • Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.	0.00% 0/6 • Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.	8.3% 1/12 • Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.
Cardiac disorders Cardiac arrest	16.7% 1/6 • Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.	0.00% 0/12 • Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.	16.7% 1/6 • Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.	0.00% 0/12 • Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.
General disorders Disease progression	0.00% 0/6 • Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.	0.00% 0/12 • Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.	16.7% 1/6 • Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.	16.7% 2/12 • Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.
Metabolism and nutrition disorders Hypokalaemia	16.7% 1/6 • Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.	0.00% 0/12 • Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.	16.7% 1/6 • Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.	0.00% 0/12 • Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/6 • Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.	8.3% 1/12 • Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.	0.00% 0/6 • Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.	8.3% 1/12 • Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/6 • Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.	8.3% 1/12 • Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.	0.00% 0/6 • Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.	8.3% 1/12 • Part A: Day 1 through Week 6 Part A + Part B: up to 24 weeks The same event may appear as both an AE and an SAE. 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 nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

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