PF-06954522

An adverse event (AEs) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. Serious AE (SAE) was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect. AEs included SAEs and non-SAEs.

An AEs was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. SAE was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect. AEs included SAEs and non-SAEs.

An AEs was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. SAE was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect. AEs included SAEs and non-SAEs.

Planned hematology laboratory tests included: hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.

Planned hematology laboratory tests included: hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.

Planned hematology laboratory tests included: hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.

Planned chemistry laboratory tests included: blood urea nitrogen, creatinine, cystatin C, estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium. chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase, alkaline phosphatase, creatine kinase, uric acid, albumin and total protein. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.

Planned chemistry laboratory tests included: blood urea nitrogen, creatinine, cystatin C, estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium. chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase, alkaline phosphatase, creatine kinase, uric acid, albumin and total protein. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.

Planned chemistry laboratory tests included: blood urea nitrogen, creatinine, cystatin C, estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium. chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase, alkaline phosphatase, creatine kinase, uric acid, albumin and total protein. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.

Planned urinalysis laboratory tests included: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen and urine bilirubin. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.

Planned urinalysis laboratory tests included: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen and urine bilirubin. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.

Planned urinalysis laboratory tests included: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen and urine bilirubin. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.

Vital signs parameters were summarized according to pre-specified categorization of data: supine systolic blood pressure: Value less than (\<) 90 millimeter of mercury (mmHg), increase or decrease from baseline \>= 30mmHg, supine diastolic blood pressure: value \<50 mmHg, increase or decrease from baseline \>= 20mmHg and supine pulse rate: Value \< 40 beats per minute bpm or \> 120bpm.

Vital signs parameters were summarized according to pre-specified categorization of data: supine systolic blood pressure: Value less than (\<) 90 millimeter of mercury (mmHg), increase or decrease from baseline \>= 30mmHg, supine diastolic blood pressure: value \<50 mmHg, increase or decrease from baseline \>= 20mmHg and supine pulse rate: Value \< 40 beats per minute bpm or \> 120bpm.

Vital signs parameters were summarized according to pre-specified categorization of data: supine systolic blood pressure: Value less than (\<) 90 millimeter of mercury (mmHg), increase or decrease from baseline \>= 30mmHg, supine diastolic blood pressure: value \<50 mmHg and increase or decrease from baseline \>= 20mmHg.

Pre-specified ECG abnormalities criteria : PR interval millisecond (msec), value \>=300, baseline \> 200 and percentage (%) change \>=25%, baseline \<=200 and percentage change \>=50%; QRS duration (msec): value \>=140, % change\>= 50%; corrected QT interval using Fridericia's formula (QTcF) (msec): 450 \< value \<= 480, 480\<= value \<500, value \>=500, 30\<= change \<60 and change \> 60.

Pre-specified ECG abnormalities criteria : PR interval millisecond (msec), value \>=300, baseline \> 200 and percentage (%) change \>=25%, baseline \<=200 and percentage change \>=50%; QRS duration (msec): value \>=140, % change\>= 50%; corrected QT interval using Fridericia's formula (QTcF) (msec): 450 \< value \<= 480, 480\<= value \<500, value \>=500, 30\<= change \<60 and change \> 60.

Pre-specified ECG abnormalities criteria : PR interval millisecond (msec), value \>=300, baseline \> 200 and percentage (%) change \>=25%, baseline \<=200 and percentage change \>=50%; QRS duration (msec): value \>=140, % change\>= 50%; corrected QT interval using Fridericia's formula (QTcF) (msec): 450 \< value \<= 480, 480\<= value \<500, value \>=500, 30\<= change \<60 and change \> 60.