Trial Outcomes & Findings for An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study (NCT NCT05192200)
NCT ID: NCT05192200
Last Updated: 2025-02-06
Results Overview
An Adverse Event (AE) 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 treatment emergent relative to a given treatment if the event occurred for the first time during the effective duration of treatment and was not seen prior to the start of treatment, or the event was seen prior to the start of treatment but increased in severity during treatment. AEs included both serious adverse events (SAEs) and all non-SAEs.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
From Day 1 of dosing maximum up to Week 68
Results posted on
2025-02-06
Participant Flow
Eligible participants with moderate to severe dermatomyositis (DM) who completed the treatment period of qualifying study C0251002 \[NCT03181893\] and had agreement from their study doctor to continue active treatment were enrolled in this study. A total of 24 participants (9 participants from the skin predominant cohort \[Amended stage 2\] and 15 participants from the muscle predominant cohort \[Stage 3\]) of the study C0251002 were enrolled in this open label, long-term extension (OLE) study.
As planned, in participant flow discontinuations were reported by treatment.
Participant milestones
| Measure |
PF-06823859 600mg: All Participants
Participants with DM received PF-06823859 600 milligrams (mg) intravenously (IV) once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
|---|---|
|
Treatment Period
STARTED
|
24
|
|
Treatment Period
Safety Analysis Set
|
24
|
|
Treatment Period
Skin Analysis Set
|
9
|
|
Treatment Period
Muscle Analysis Set
|
15
|
|
Treatment Period
COMPLETED
|
21
|
|
Treatment Period
NOT COMPLETED
|
3
|
|
Follow-up
STARTED
|
22
|
|
Follow-up
COMPLETED
|
21
|
|
Follow-up
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
PF-06823859 600mg: All Participants
Participants with DM received PF-06823859 600 milligrams (mg) intravenously (IV) once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
|---|---|
|
Treatment Period
Other
|
1
|
|
Treatment Period
Lack of Efficacy
|
1
|
|
Treatment Period
Withdrawal by Subject
|
1
|
|
Follow-up
Withdrawal by Subject
|
1
|
Baseline Characteristics
Here, Number analyzed refers to number of participants analyzed per row.
Baseline characteristics by cohort
| Measure |
PF-06823859 600mg: All Participants
n=24 Participants
Participants with DM received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
|---|---|
|
Age, Continuous
All Participants
|
49.79 Years
STANDARD_DEVIATION 12.73 • n=24 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Age, Continuous
Skin Cohort
|
51.78 Years
STANDARD_DEVIATION 10.32 • n=9 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Age, Continuous
Muscle Cohort
|
48.60 Years
STANDARD_DEVIATION 14.19 • n=15 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Sex: Female, Male
All Participants · Female
|
20 Participants
n=24 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Sex: Female, Male
All Participants · Male
|
4 Participants
n=24 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Sex: Female, Male
Skin Cohort · Female
|
9 Participants
n=9 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Sex: Female, Male
Skin Cohort · Male
|
0 Participants
n=9 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Sex: Female, Male
Muscle Cohort · Female
|
11 Participants
n=15 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Sex: Female, Male
Muscle Cohort · Male
|
4 Participants
n=15 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Ethnicity (NIH/OMB)
All Participants · Hispanic or Latino
|
5 Participants
n=24 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Ethnicity (NIH/OMB)
All Participants · Not Hispanic or Latino
|
19 Participants
n=24 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Ethnicity (NIH/OMB)
All Participants · Unknown or Not Reported
|
0 Participants
n=24 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Ethnicity (NIH/OMB)
Skin Cohort · Hispanic or Latino
|
1 Participants
n=9 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Ethnicity (NIH/OMB)
Skin Cohort · Not Hispanic or Latino
|
8 Participants
n=9 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Ethnicity (NIH/OMB)
Skin Cohort · Unknown or Not Reported
|
0 Participants
n=9 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Ethnicity (NIH/OMB)
Muscle Cohort · Hispanic or Latino
|
4 Participants
n=15 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Ethnicity (NIH/OMB)
Muscle Cohort · Not Hispanic or Latino
|
11 Participants
n=15 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Ethnicity (NIH/OMB)
Muscle Cohort · Unknown or Not Reported
|
0 Participants
n=15 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Race (NIH/OMB)
All Participants · American Indian or Alaska Native
|
0 Participants
n=24 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Race (NIH/OMB)
All Participants · Asian
|
0 Participants
n=24 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Race (NIH/OMB)
All Participants · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Race (NIH/OMB)
All Participants · Black or African American
|
0 Participants
n=24 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Race (NIH/OMB)
All Participants · White
|
24 Participants
n=24 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Race (NIH/OMB)
All Participants · More than one race
|
0 Participants
n=24 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Race (NIH/OMB)
All Participants · Unknown or Not Reported
|
0 Participants
n=24 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Race (NIH/OMB)
Skin Cohort · American Indian or Alaska Native
|
0 Participants
n=9 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Race (NIH/OMB)
Skin Cohort · Asian
|
0 Participants
n=9 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Race (NIH/OMB)
Skin Cohort · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Race (NIH/OMB)
Skin Cohort · Black or African American
|
0 Participants
n=9 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Race (NIH/OMB)
Skin Cohort · White
|
9 Participants
n=9 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Race (NIH/OMB)
Skin Cohort · More than one race
|
0 Participants
n=9 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Race (NIH/OMB)
Skin Cohort · Unknown or Not Reported
|
0 Participants
n=9 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Race (NIH/OMB)
Muscle Cohort · American Indian or Alaska Native
|
0 Participants
n=15 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Race (NIH/OMB)
Muscle Cohort · Asian
|
0 Participants
n=15 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Race (NIH/OMB)
Muscle Cohort · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Race (NIH/OMB)
Muscle Cohort · Black or African American
|
0 Participants
n=15 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Race (NIH/OMB)
Muscle Cohort · White
|
15 Participants
n=15 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Race (NIH/OMB)
Muscle Cohort · More than one race
|
0 Participants
n=15 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
|
Race (NIH/OMB)
Muscle Cohort · Unknown or Not Reported
|
0 Participants
n=15 Participants • Here, Number analyzed refers to number of participants analyzed per row.
|
PRIMARY outcome
Timeframe: From Day 1 of dosing maximum up to Week 68Population: Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for skin cohort/analysis set, muscle cohort/analysis set and all participants/safety analysis set.
An Adverse Event (AE) 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 treatment emergent relative to a given treatment if the event occurred for the first time during the effective duration of treatment and was not seen prior to the start of treatment, or the event was seen prior to the start of treatment but increased in severity during treatment. AEs included both serious adverse events (SAEs) and all non-SAEs.
Outcome measures
| Measure |
PF-06823859 600mg: Skin Cohort
n=9 Participants
Participants with skin predominant DM entering from amended stage 2 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: Muscle Cohort
n=15 Participants
Participants with muscle predominant DM entering from stage 3 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: All Participants
n=24 Participants
Participants with DM received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
7 Participants
|
13 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: From Day 1 of dosing maximum up to Week 68Population: Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for skin cohort/analysis set, muscle cohort/analysis set and all participants/safety analysis set.
Hematology laboratory parameters: hemoglobin (grams per deciliter \[g/dL\]); hematocrit (percentage \[%\]); lymphocytes (10\^3 per (/) millimeter\[mm\]\^3); lymphocytes/leukocytes (%); neutrophils (10\^3/mm\^3) less than (\<)0.8\*lower limit of normal (LLN), leukocytes (10\^3/mm\^3) \<0.6\*LLN, neutrophils (10\^3/mm\^3); basophils (10\^3/mm\^3); basophils/leukocytes (%); monocytes/leukocytes (%); activated partial thromboplastin time (seconds \[sec\]); prothrombin time (sec) more than (\>)1.2\*upper limit of normal (ULN). Clinical chemistry: potassium (milliequivalents per liter \[mEq/L\]); bicarbonate (mEq/L) \<0.9\*LLN, creatine kinase (units per liter \[U/L\]) \>2.0\*ULN, glucose (milligram per deciliter \[mg/dl\]); glucose-fasting (mg/dl) \>1.5\*ULN. Urinalysis: Urine glucose; ketones; urine protein; urine hemoglobin; nitrite; leukocyte esterase; hyaline casts (1/per leukocytosis promoting factor (more than or equal to \[\>=\] 1, urine erythrocytes (scalar); urine leukocytes (scalar) \>=20.
Outcome measures
| Measure |
PF-06823859 600mg: Skin Cohort
n=9 Participants
Participants with skin predominant DM entering from amended stage 2 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: Muscle Cohort
n=15 Participants
Participants with muscle predominant DM entering from stage 3 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: All Participants
n=24 Participants
Participants with DM received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities
|
8 Participants
|
14 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: From Day 1 of dosing maximum up to Week 68Population: Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for skin cohort/analysis set, muscle cohort/analysis set and all participants/safety analysis set.
Vital signs included the following parameters: sitting diastolic blood pressure (millimetres of mercury \[mmHg\]) change \>=20 mmHg increase; sitting systolic blood pressure (mmHg) change \>=30 mmHg increase, sitting diastolic blood pressure (mmHg) change \>=20 mmHg decrease and sitting systolic blood pressure (mmHg) change \>=30 mmHg decrease.
Outcome measures
| Measure |
PF-06823859 600mg: Skin Cohort
n=9 Participants
Participants with skin predominant DM entering from amended stage 2 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: Muscle Cohort
n=15 Participants
Participants with muscle predominant DM entering from stage 3 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: All Participants
n=24 Participants
Participants with DM received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
|---|---|---|---|
|
Number of Participants According to Categorization of Changes in Vital Signs
Increase: sitting diastolic blood pressure (mmHg)
|
4 Participants
|
4 Participants
|
8 Participants
|
|
Number of Participants According to Categorization of Changes in Vital Signs
Increase: sitting systolic blood pressure (mmHg)
|
4 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants According to Categorization of Changes in Vital Signs
Decrease: sitting diastolic blood pressure (mmHg)
|
1 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants According to Categorization of Changes in Vital Signs
Decrease: sitting systolic blood pressure (mmHg)
|
1 Participants
|
3 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: From Day 1 of dosing maximum up to Week 68Population: Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for skin cohort/analysis set, muscle cohort/analysis set and all participants/safety analysis set.
ECG parameters evaluated were: PR interval value \>=300 milliseconds (msec); QRS duration value \>=200 msec; QT interval value \>=500 msec; corrected QT Interval using Fridericia's formula (QTCF) 450 less than or equal to (\<=) value \<480 msec, 480 \<=value\<500 msec and value\>=500 msec.
Outcome measures
| Measure |
PF-06823859 600mg: Skin Cohort
n=9 Participants
Participants with skin predominant DM entering from amended stage 2 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: Muscle Cohort
n=15 Participants
Participants with muscle predominant DM entering from stage 3 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: All Participants
n=24 Participants
Participants with DM received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
|---|---|---|---|
|
Number of Participants According to Categorization of Electrocardiogram (ECG) Findings
QTCF: 480<=value<500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Categorization of Electrocardiogram (ECG) Findings
PR interval: value >=300 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Categorization of Electrocardiogram (ECG) Findings
QRS duration: value >=200 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Categorization of Electrocardiogram (ECG) Findings
QT interval: >=500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Categorization of Electrocardiogram (ECG) Findings
QTCF: 450<=value<480 msec
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants According to Categorization of Electrocardiogram (ECG) Findings
QTCF: value>=500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (before dose 1), Week 52Population: Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for skin cohort/analysis set and muscle cohort/analysis set. Here, "Number of Participants Analyzed" signifies number evaluable for this outcome measure.
CDASI is a validated DM-specific instrument designed to systematically quantify the extent of cutaneous disease. Disease involvement in 15 different anatomical locations was rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia were also captured. Total CDASI activity score was based on the physician's evaluation of three activities (erythema, scale, erosion/ulceration), presence and severity of Gottron's papules, periungual changes and alopecia. Total CDASI activity score ranged from 0 to 100, where higher scores indicated higher levels of disability.
Outcome measures
| Measure |
PF-06823859 600mg: Skin Cohort
n=9 Participants
Participants with skin predominant DM entering from amended stage 2 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: Muscle Cohort
n=12 Participants
Participants with muscle predominant DM entering from stage 3 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: All Participants
Participants with DM received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
|---|---|---|---|
|
Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 52
|
-4.67 Units on a scale
Interval -7.41 to -1.92
|
-2.51 Units on a scale
Interval -3.4 to -1.62
|
—
|
SECONDARY outcome
Timeframe: Baseline (before dose 1), Weeks 12, 24, 36 and 48Population: Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for skin cohort/analysis set and muscle cohort/analysis set. Here "Number Analyzed" signifies number of participants evaluable for specified rows.
CDASI is a validated DM-specific instrument designed to systematically quantify the extent of cutaneous disease. Disease involvement in 15 different anatomical locations was rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia were also captured. Total CDASI activity score was based on the physician's evaluation of three activities (erythema, scale, erosion/ulceration), presence and severity of Gottron's papules, periungual changes and alopecia. Total CDASI activity score ranged from 0 to 100, where higher scores indicated higher levels of disability.
Outcome measures
| Measure |
PF-06823859 600mg: Skin Cohort
n=9 Participants
Participants with skin predominant DM entering from amended stage 2 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: Muscle Cohort
n=15 Participants
Participants with muscle predominant DM entering from stage 3 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: All Participants
Participants with DM received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
|---|---|---|---|
|
Change From Baseline in CDASI Activity Score at Weeks 12, 24, 36, and 48
Change at Week 12
|
-5.28 Units on a scale
Interval -7.67 to -2.9
|
-0.87 Units on a scale
Interval -1.98 to 0.25
|
—
|
|
Change From Baseline in CDASI Activity Score at Weeks 12, 24, 36, and 48
Change at Week 24
|
-4.11 Units on a scale
Interval -6.47 to -1.75
|
-0.67 Units on a scale
Interval -2.09 to 0.75
|
—
|
|
Change From Baseline in CDASI Activity Score at Weeks 12, 24, 36, and 48
Change at Week 36
|
-4.51 Units on a scale
Interval -7.9 to -1.11
|
-1.40 Units on a scale
Interval -2.4 to -0.4
|
—
|
|
Change From Baseline in CDASI Activity Score at Weeks 12, 24, 36, and 48
Change at Week 48
|
-4.56 Units on a scale
Interval -7.27 to -1.84
|
-1.70 Units on a scale
Interval -2.7 to -0.7
|
—
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 36, 48 and 52Population: Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for skin cohort/analysis set and muscle cohort/analysis set. Here, "Number Analyzed" signifies number evaluable for specified rows.
CDASI is a validated DM-specific instrument designed to systematically quantify the extent of cutaneous disease. Disease involvement in 15 different anatomical locations was rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia were also captured. Total CDASI activity score was based on the physician's evaluation of three activities (erythema, scale, erosion/ulceration), presence and severity of Gottron's papules, periungual changes and alopecia. Total CDASI activity score ranged from 0 to 100, where higher scores indicated higher levels of disability.
Outcome measures
| Measure |
PF-06823859 600mg: Skin Cohort
n=9 Participants
Participants with skin predominant DM entering from amended stage 2 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: Muscle Cohort
n=15 Participants
Participants with muscle predominant DM entering from stage 3 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: All Participants
Participants with DM received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
|---|---|---|---|
|
Absolute Values of CDASI Activity Score at Weeks 12, 24, 36, 48, and 52
Week 12
|
4.4 Units on a scale
Standard Deviation 2.45
|
4.4 Units on a scale
Standard Deviation 3.44
|
—
|
|
Absolute Values of CDASI Activity Score at Weeks 12, 24, 36, 48, and 52
Week 24
|
5.0 Units on a scale
Standard Deviation 3.71
|
4.6 Units on a scale
Standard Deviation 3.81
|
—
|
|
Absolute Values of CDASI Activity Score at Weeks 12, 24, 36, 48, and 52
Week 36
|
5.5 Units on a scale
Standard Deviation 5.13
|
3.9 Units on a scale
Standard Deviation 3.27
|
—
|
|
Absolute Values of CDASI Activity Score at Weeks 12, 24, 36, 48, and 52
Week 48
|
4.6 Units on a scale
Standard Deviation 4.45
|
3.1 Units on a scale
Standard Deviation 3.03
|
—
|
|
Absolute Values of CDASI Activity Score at Weeks 12, 24, 36, 48, and 52
Week 52
|
4.4 Units on a scale
Standard Deviation 4.85
|
2.2 Units on a scale
Standard Deviation 2.52
|
—
|
SECONDARY outcome
Timeframe: Baseline (before dose on Day 1), Weeks 12, 24, 36, 48 and 52Population: Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for skin cohort/analysis set and muscle cohort/analysis set. Here "Number Analyzed" signifies number evaluable for specified rows.
CDASI is a validated DM-specific instrument designed to systematically quantify the extent of cutaneous disease. Disease involvement in 15 different anatomical locations was rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia were also captured. Total CDASI damage score was based on the physician's evaluation of two damage (poikiloderma, calcinosis) measures, and presence and severity of Gottron's papules. Total CDASI damage score ranged from 0 to 32, where higher scores indicated higher level of skin damage.
Outcome measures
| Measure |
PF-06823859 600mg: Skin Cohort
n=9 Participants
Participants with skin predominant DM entering from amended stage 2 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: Muscle Cohort
n=15 Participants
Participants with muscle predominant DM entering from stage 3 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: All Participants
Participants with DM received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
|---|---|---|---|
|
Change From Baseline in CDASI Damage Score at Weeks 12, 24, 36, 48, and 52
Change at Week 12
|
-2.4 Units on a scale
Standard Deviation 2.77
|
-0.8 Units on a scale
Standard Deviation 1.15
|
—
|
|
Change From Baseline in CDASI Damage Score at Weeks 12, 24, 36, 48, and 52
Change at Week 24
|
-1.8 Units on a scale
Standard Deviation 2.33
|
-0.5 Units on a scale
Standard Deviation 1.19
|
—
|
|
Change From Baseline in CDASI Damage Score at Weeks 12, 24, 36, 48, and 52
Change at Week 36
|
-2.3 Units on a scale
Standard Deviation 2.25
|
-0.5 Units on a scale
Standard Deviation 1.06
|
—
|
|
Change From Baseline in CDASI Damage Score at Weeks 12, 24, 36, 48, and 52
Change at Week 48
|
-2.0 Units on a scale
Standard Deviation 2.00
|
-0.9 Units on a scale
Standard Deviation 1.24
|
—
|
|
Change From Baseline in CDASI Damage Score at Weeks 12, 24, 36, 48, and 52
Change at Week 52
|
-2.1 Units on a scale
Standard Deviation 2.09
|
-0.9 Units on a scale
Standard Deviation 1.08
|
—
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 36, 48 and 52Population: Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for skin cohort/analysis set and muscle cohort/analysis set. Here "Number Analyzed" signifies number evaluable for specified rows.
CDASI is a validated DM-specific instrument designed to systematically quantify the extent of cutaneous disease. Disease involvement in 15 different anatomical locations was rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia were also captured. Total CDASI damage score was based on the physician's evaluation of two damage (poikiloderma, calcinosis) measures, and presence and severity of Gottron's papules. Total CDASI damage score ranged from 0 to 32, where higher scores indicated higher level of skin damage.
Outcome measures
| Measure |
PF-06823859 600mg: Skin Cohort
n=9 Participants
Participants with skin predominant DM entering from amended stage 2 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: Muscle Cohort
n=15 Participants
Participants with muscle predominant DM entering from stage 3 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: All Participants
Participants with DM received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
|---|---|---|---|
|
Absolute Values of CDASI Damage Score at Weeks 12, 24, 36, 48, and 52
Week 48
|
1.7 Units on a scale
Standard Deviation 2.12
|
1.3 Units on a scale
Standard Deviation 2.83
|
—
|
|
Absolute Values of CDASI Damage Score at Weeks 12, 24, 36, 48, and 52
Week 24
|
1.9 Units on a scale
Standard Deviation 2.26
|
1.9 Units on a scale
Standard Deviation 3.41
|
—
|
|
Absolute Values of CDASI Damage Score at Weeks 12, 24, 36, 48, and 52
Week 36
|
1.4 Units on a scale
Standard Deviation 2.33
|
1.9 Units on a scale
Standard Deviation 3.43
|
—
|
|
Absolute Values of CDASI Damage Score at Weeks 12, 24, 36, 48, and 52
Week 12
|
0.9 Units on a scale
Standard Deviation 1.25
|
1.6 Units on a scale
Standard Deviation 3.07
|
—
|
|
Absolute Values of CDASI Damage Score at Weeks 12, 24, 36, 48, and 52
Week 52
|
1.6 Units on a scale
Standard Deviation 1.59
|
1.3 Units on a scale
Standard Deviation 3.19
|
—
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 36, 48 and 52Population: Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for muscle cohort/analysis set. Here "Number Analyzed" signifies number evaluable for specified rows.
There are 6 core set measure that comprised of TIS: 1) Physician Global Assessment Score \[PhGA\] (from Myositis Disease Activity Assessment Tool \[MDAAT\], 0-100 mm or 0-10 centimeter (cm) on visual analogue scale \[VAS\], higher scores= worse health status); 2) Patient Global Assessment Score \[PtGA\] (0-100 mm or 0-10 cm on VAS, higher scores= worse status); 3) Manual Muscle Testing-8 (MMT-8) designated muscle groups (0-80, lower scores= higher level of disability); 4) Health Assessment Questionnaire Disability Index \[HAQ-DI\] (0-3, higher scores= worse status); 5) Global Extramuscular Disease Activity (from MDAAT, 0-10 cm on a VAS, higher scores= higher level of disability); 6) Participant's most elevated muscle enzymes. TIS was sum of all 6 improvement scores associated with the change in each core set measure. TIS ranged from 0 to 100; where TIS\>=20 shows minimal improvement, TIS \>=40 shows moderate improvement and TIS \>= 60 shows major improvement.
Outcome measures
| Measure |
PF-06823859 600mg: Skin Cohort
n=15 Participants
Participants with skin predominant DM entering from amended stage 2 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: Muscle Cohort
Participants with muscle predominant DM entering from stage 3 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: All Participants
Participants with DM received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
|---|---|---|---|
|
Total Improvement Score (TIS) at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Week 12
|
15.03 Units on a scale
Interval 8.36 to 21.7
|
—
|
—
|
|
Total Improvement Score (TIS) at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Week 24
|
15.67 Units on a scale
Interval 8.96 to 22.37
|
—
|
—
|
|
Total Improvement Score (TIS) at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Week 36
|
18.17 Units on a scale
Interval 10.84 to 25.49
|
—
|
—
|
|
Total Improvement Score (TIS) at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Week 48
|
19.61 Units on a scale
Interval 10.58 to 28.63
|
—
|
—
|
|
Total Improvement Score (TIS) at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Week 52
|
23.66 Units on a scale
Interval 14.05 to 33.28
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (before dose on day 1), Weeks 12, 24, 36, 48 and 52Population: Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for muscle cohort/analysis set. Here "Number Analyzed" signifies number evaluable for specified rows.
PhGA: Investigator was asked to evaluate the participant's overall disease activity on a VAS of 0 cm (very good) to 10 cm (very poor), higher scores indicated worse health status.
Outcome measures
| Measure |
PF-06823859 600mg: Skin Cohort
n=15 Participants
Participants with skin predominant DM entering from amended stage 2 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: Muscle Cohort
Participants with muscle predominant DM entering from stage 3 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: All Participants
Participants with DM received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
|---|---|---|---|
|
Change From Baseline in Physician Global Assessment (PhGA) Score at Week 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 12
|
0.17 centimeter
Interval -0.54 to 0.87
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PhGA) Score at Week 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 24
|
0.29 centimeter
Interval -0.39 to 0.98
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PhGA) Score at Week 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 36
|
-0.18 centimeter
Interval -0.59 to 0.23
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PhGA) Score at Week 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 48
|
-0.48 centimeter
Interval -0.85 to -0.1
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PhGA) Score at Week 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 52
|
-0.60 centimeter
Interval -0.97 to -0.23
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (before dose on day 1), Weeks 12, 24, 36, 48 and 52Population: Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for muscle cohort/analysis set. Here "Number Analyzed" signifies number evaluable for specified rows.
PtGA was the assessment of the severity of disease by the participant/participant's guardian, using a VAS from 0 mm (no evidence of disease activity) to 100 mm (extremely active or severe disease activity). Higher score indicated worse status.
Outcome measures
| Measure |
PF-06823859 600mg: Skin Cohort
n=15 Participants
Participants with skin predominant DM entering from amended stage 2 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: Muscle Cohort
Participants with muscle predominant DM entering from stage 3 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: All Participants
Participants with DM received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
|---|---|---|---|
|
Change From Baseline in Patient Global Assessment (PtGA) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 12
|
3.70 millimeter
Interval -6.55 to 13.95
|
—
|
—
|
|
Change From Baseline in Patient Global Assessment (PtGA) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 24
|
-9.63 millimeter
Interval -18.18 to -1.08
|
—
|
—
|
|
Change From Baseline in Patient Global Assessment (PtGA) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 36
|
-9.10 millimeter
Interval -16.47 to -1.73
|
—
|
—
|
|
Change From Baseline in Patient Global Assessment (PtGA) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 48
|
-8.36 millimeter
Interval -14.74 to -1.97
|
—
|
—
|
|
Change From Baseline in Patient Global Assessment (PtGA) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 52
|
-6.28 millimeter
Interval -16.79 to 4.22
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (before dose on day 1), Weeks 12, 24, 36, 48 and 52Population: Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for muscle cohort/analysis set. Here "Number Analyzed" signifies number evaluable for specified rows.
MMT-8 is a tool that assesses muscle strength using manual muscle testing. Eight designated muscles are tested unilaterally with a total potential summed score of 0-80. Lower scores indicated a higher level of disability.
Outcome measures
| Measure |
PF-06823859 600mg: Skin Cohort
n=15 Participants
Participants with skin predominant DM entering from amended stage 2 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: Muscle Cohort
Participants with muscle predominant DM entering from stage 3 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: All Participants
Participants with DM received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
|---|---|---|---|
|
Change From Baseline in Manual Muscle Testing-8 Designated Muscle Groups (MMT-8) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 12
|
-0.06 Units on a scale
Interval -5.93 to 5.82
|
—
|
—
|
|
Change From Baseline in Manual Muscle Testing-8 Designated Muscle Groups (MMT-8) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 24
|
1.85 Units on a scale
Interval -3.11 to 6.81
|
—
|
—
|
|
Change From Baseline in Manual Muscle Testing-8 Designated Muscle Groups (MMT-8) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 36
|
4.92 Units on a scale
Interval 0.61 to 9.22
|
—
|
—
|
|
Change From Baseline in Manual Muscle Testing-8 Designated Muscle Groups (MMT-8) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 48
|
8.00 Units on a scale
Interval 5.69 to 10.3
|
—
|
—
|
|
Change From Baseline in Manual Muscle Testing-8 Designated Muscle Groups (MMT-8) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 52
|
9.84 Units on a scale
Interval 7.38 to 12.31
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (before dose on day 1), Weeks 12, 24, 36, 48 and 52Population: Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for muscle cohort/analysis set. Here "Number Analyzed" signifies number evaluable for specified rows.
HAQ-DI consisted of eight sections (including dressing \& grooming, arising, eating, walking, hygiene, grip, reach, and activities). Each section had multiple questions that the participant used to rank their functionality and ranged from 0 to 3 where 0 = without any difficulty and 3 = unable to do. For each participant, the average ranking was calculated for each of the eight sections. HAQ-DI had a score range of 0 to 3, where higher score reflected worse status.
Outcome measures
| Measure |
PF-06823859 600mg: Skin Cohort
n=15 Participants
Participants with skin predominant DM entering from amended stage 2 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: Muscle Cohort
Participants with muscle predominant DM entering from stage 3 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: All Participants
Participants with DM received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire and Disease Index (HAQ-DI) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 12
|
0.00 Units on a scale
Interval -0.13 to 0.13
|
—
|
—
|
|
Change From Baseline in Health Assessment Questionnaire and Disease Index (HAQ-DI) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 24
|
-0.10 Units on a scale
Interval -0.21 to 0.01
|
—
|
—
|
|
Change From Baseline in Health Assessment Questionnaire and Disease Index (HAQ-DI) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 36
|
-0.07 Units on a scale
Interval -0.23 to 0.08
|
—
|
—
|
|
Change From Baseline in Health Assessment Questionnaire and Disease Index (HAQ-DI) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 48
|
-0.12 Units on a scale
Interval -0.24 to 0.0
|
—
|
—
|
|
Change From Baseline in Health Assessment Questionnaire and Disease Index (HAQ-DI) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 52
|
-0.18 Units on a scale
Interval -0.32 to -0.04
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (before dose on day 1), Weeks 12, 24, 36, 48 and 52Population: Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for muscle cohort/analysis set. Here "Number Analyzed" signifies number evaluable for specified rows.
Creatine kinase is a muscle enzyme measured in units per liter (U/L).
Outcome measures
| Measure |
PF-06823859 600mg: Skin Cohort
n=15 Participants
Participants with skin predominant DM entering from amended stage 2 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: Muscle Cohort
Participants with muscle predominant DM entering from stage 3 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: All Participants
Participants with DM received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
|---|---|---|---|
|
Change From Baseline in Creatine Kinase at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 12
|
-98.93 Units per liter
Interval -163.76 to -34.11
|
—
|
—
|
|
Change From Baseline in Creatine Kinase at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 24
|
-58.53 Units per liter
Interval -127.24 to 10.17
|
—
|
—
|
|
Change From Baseline in Creatine Kinase at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 36
|
-97.62 Units per liter
Interval -150.82 to -44.42
|
—
|
—
|
|
Change From Baseline in Creatine Kinase at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 48
|
-72.04 Units per liter
Interval -161.48 to 17.39
|
—
|
—
|
|
Change From Baseline in Creatine Kinase at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 52
|
-94.04 Units per liter
Interval -147.13 to -40.95
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (before dose on day 1), Weeks 12, 24, 36, 48 and 52Population: Safety Analysis Set included all participants enrolled who took at least 1 dose of study intervention, regardless of which stage the participant entered from. In this outcome measure data was planned to be reported for muscle cohort/analysis set. Here "Number Analyzed" signifies number evaluable for specified rows.
MDAAT tool measures the degree of disease activity of extramuscular organ systems and muscle on a VAS of 0 to 10 cm, higher scores indicated higher level of disability.
Outcome measures
| Measure |
PF-06823859 600mg: Skin Cohort
n=15 Participants
Participants with skin predominant DM entering from amended stage 2 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: Muscle Cohort
Participants with muscle predominant DM entering from stage 3 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: All Participants
Participants with DM received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
|---|---|---|---|
|
Change From Baseline in Extramuscular Global Assessment From the Myositis Disease Activity Assessment Tool (MDAAT) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 36
|
0.01 centimeter
Interval -0.51 to 0.53
|
—
|
—
|
|
Change From Baseline in Extramuscular Global Assessment From the Myositis Disease Activity Assessment Tool (MDAAT) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 12
|
0.05 centimeter
Interval -0.4 to 0.5
|
—
|
—
|
|
Change From Baseline in Extramuscular Global Assessment From the Myositis Disease Activity Assessment Tool (MDAAT) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 24
|
0.23 centimeter
Interval -0.23 to 0.68
|
—
|
—
|
|
Change From Baseline in Extramuscular Global Assessment From the Myositis Disease Activity Assessment Tool (MDAAT) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 48
|
-0.16 centimeter
Interval -0.91 to 0.59
|
—
|
—
|
|
Change From Baseline in Extramuscular Global Assessment From the Myositis Disease Activity Assessment Tool (MDAAT) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
Change at Week 52
|
-0.56 centimeter
Interval -1.07 to -0.06
|
—
|
—
|
Adverse Events
PF-06823859 600mg: Skin Cohort
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
PF-06823859 600mg: Muscle Cohort
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
PF-06823859 600mg: All Participants
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PF-06823859 600mg: Skin Cohort
n=9 participants at risk
Participants with skin predominant DM entering from amended stage 2 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: Muscle Cohort
n=15 participants at risk
Participants with muscle predominant DM entering from stage 3 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: All Participants
n=24 participants at risk
Participants with DM received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
Other adverse events
| Measure |
PF-06823859 600mg: Skin Cohort
n=9 participants at risk
Participants with skin predominant DM entering from amended stage 2 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: Muscle Cohort
n=15 participants at risk
Participants with muscle predominant DM entering from stage 3 of study C0251002 \[NCT03181893\] received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
PF-06823859 600mg: All Participants
n=24 participants at risk
Participants with DM received PF-06823859 600 mg IV once every 4 weeks. The treatment duration was up to 48 weeks (treatment period was up through and including Week 52). There was a follow-up period of 16 weeks post treatment period, however participants were assessed for safety from Day 1 of treatment up to end of study (Week 68).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
8.3%
2/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Cardiac disorders
Palpitations
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
13.3%
2/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
8.3%
2/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
General disorders
Calcinosis
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
General disorders
Chest discomfort
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
General disorders
Infusion site extravasation
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
General disorders
Infusion site rash
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
General disorders
Pyrexia
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Infections and infestations
Bronchitis
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
8.3%
2/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Infections and infestations
COVID-19
|
33.3%
3/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
20.0%
3/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
25.0%
6/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Infections and infestations
Cystitis
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Infections and infestations
Fungal infection
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Infections and infestations
Influenza
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Infections and infestations
Laryngitis
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Infections and infestations
Respiratory tract infection viral
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Infections and infestations
Sinusitis
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
8.3%
2/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Infections and infestations
Tooth infection
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Infections and infestations
Upper respiratory tract infection
|
22.2%
2/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
8.3%
2/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
13.3%
2/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
12.5%
3/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Injury, poisoning and procedural complications
Fall
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Investigations
Blood potassium decreased
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Investigations
Blood pressure increased
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Investigations
Crystal urine present
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Investigations
Weight increased
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
8.3%
2/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
13.3%
2/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
8.3%
2/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
13.3%
2/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
8.3%
2/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Nervous system disorders
Presyncope
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Renal and urinary disorders
Acute kidney injury
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
2/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
8.3%
2/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Skin and subcutaneous tissue disorders
Cutaneous calcification
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Skin and subcutaneous tissue disorders
Nail pigmentation
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
8.3%
2/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Vascular disorders
Hypotension
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Vascular disorders
Lymphoedema
|
11.1%
1/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
0.00%
0/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/9 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
6.7%
1/15 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
4.2%
1/24 • From Day 1 of dosing maximum up to Week 68
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled who had taken at least 1 dose of study intervention. This included all such participants regardless of which parent study or stage the participant entered from.
|
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