Trial Outcomes & Findings for Open-label Extension to the Phase 2 Crossover Study (PRESIDIO) Evaluating KZR-616 in Patients With PM and DM. (NCT NCT04628936)
NCT ID: NCT04628936
Last Updated: 2025-11-19
Results Overview
The mean Total Improvement Score (TIS) at OLE Week 48, which ranges from 0 to 100 \[low of 0 to high of 100, where higher scores are better\]. The timeframe of 48 weeks was selected because it represented the maximum timeframe of dosing for the last patient enrolled as the study drug administration ended when the last patient enrolled completed 48 weeks of dosing.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
48 weeks
Results posted on
2025-11-19
Participant Flow
Participant milestones
| Measure |
KZR-616 45 mg + Standard Therapy (Open-label)
All patients received SC injections of KZR-616 once weekly (QW) at doses of 30 mg on day 1 and 45 mg thereafter for up to 96 weeks. Study drug administration ended when the last enrolled patient completed 48 weeks of dosing in the OLE. Patients had an end of study visit 12 weeks after the last dose of KZR-616.
KZR-616: zetomipzomib subcutaneous injection
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-label Extension to the Phase 2 Crossover Study (PRESIDIO) Evaluating KZR-616 in Patients With PM and DM.
Baseline characteristics by cohort
| Measure |
KZR-616 45 mg + Standard Therapy (Open-label)
n=18 Participants
All patients received SC injections of KZR-616 QW at doses of 30 mg on day 1 and 45 mg thereafter for up to 96 weeks. Study drug administration ended when the last enrolled patient completed 48 weeks of dosing in the OLE. Patients had an end of study visit 12 weeks after the last dose of KZR-616.
KZR-616: zetomipzomib subcutaneous injection
|
|---|---|
|
Age, Continuous
|
52.7 years
STANDARD_DEVIATION 14.3
|
|
Sex: Female, Male
Female
|
13 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: Nine (9) patients were enrolled in the OLE study at Week 48.
The mean Total Improvement Score (TIS) at OLE Week 48, which ranges from 0 to 100 \[low of 0 to high of 100, where higher scores are better\]. The timeframe of 48 weeks was selected because it represented the maximum timeframe of dosing for the last patient enrolled as the study drug administration ended when the last patient enrolled completed 48 weeks of dosing.
Outcome measures
| Measure |
KZR-616 45 mg + Standard Therapy (Open-label)
n=9 Participants
All patients received SC injections of KZR-616 QW at doses of 30 mg on day 1 and 45 mg thereafter for up to 96 weeks. Study drug administration ended when the last enrolled patient completed 48 weeks of dosing in the OLE. Patients had an end of study visit 12 weeks after the last dose of KZR-616.
KZR-616: zetomipzomib subcutaneous injection
|
|---|---|
|
Mean Total Improvement Score (TIS) at OLE Week 48
|
36.4 score on a scale
Standard Deviation 23.2
|
Adverse Events
KZR-616 45 mg + Standard Therapy (Open-label)
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
KZR-616 45 mg + Standard Therapy (Open-label)
n=18 participants at risk
All patients received SC injections of KZR-616 QW at doses of 30 mg on day 1 and 45 mg thereafter for up to 96 weeks. Study drug administration ended when the last enrolled patient completed 48 weeks of dosing in the OLE. Patients had an end of study visit 12 weeks after the last dose of KZR-616.
KZR-616: zetomipzomib subcutaneous injection
|
|---|---|
|
Cardiac disorders
Wellens' syndrome
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
Other adverse events
| Measure |
KZR-616 45 mg + Standard Therapy (Open-label)
n=18 participants at risk
All patients received SC injections of KZR-616 QW at doses of 30 mg on day 1 and 45 mg thereafter for up to 96 weeks. Study drug administration ended when the last enrolled patient completed 48 weeks of dosing in the OLE. Patients had an end of study visit 12 weeks after the last dose of KZR-616.
KZR-616: zetomipzomib subcutaneous injection
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Cardiac disorders
Diastolic dysfunction
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Cardiac disorders
Pericardial effusion
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Eye disorders
Dry eye
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Eye disorders
Keratitis
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • Number of events 2 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Gastrointestinal disorders
Diarrhoea
|
27.8%
5/18 • Number of events 6 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
11.1%
2/18 • Number of events 2 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Gastrointestinal disorders
Dysphagia
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Gastrointestinal disorders
Hiatus hernia
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
6/18 • Number of events 31 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
4/18 • Number of events 8 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
General disorders
Asthenia
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
General disorders
Chest pain
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
General disorders
Chills
|
22.2%
4/18 • Number of events 14 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
General disorders
Fatigue
|
16.7%
3/18 • Number of events 41 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
General disorders
Influenza like illness
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
General disorders
Infusion site reaction
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
General disorders
Injection site bruising
|
16.7%
3/18 • Number of events 47 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
General disorders
Injection site erythema
|
22.2%
4/18 • Number of events 98 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
General disorders
Injection site exfoliation
|
5.6%
1/18 • Number of events 2 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
General disorders
Injection site induration
|
16.7%
3/18 • Number of events 6 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
General disorders
Injection site inflammation
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
General disorders
Injection site irritation
|
5.6%
1/18 • Number of events 2 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
General disorders
Injection site pain
|
5.6%
1/18 • Number of events 10 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
General disorders
Injection site pruritus
|
11.1%
2/18 • Number of events 24 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
General disorders
Injection site rash
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
General disorders
Injection site reaction
|
44.4%
8/18 • Number of events 177 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
General disorders
Injection site swelling
|
11.1%
2/18 • Number of events 33 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
General disorders
Injection site urticaria
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
General disorders
Injection site vesicles
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
General disorders
Oedema peripheral
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
General disorders
Pain
|
27.8%
5/18 • Number of events 38 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
General disorders
Pyrexia
|
27.8%
5/18 • Number of events 18 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
General disorders
Vaccination site pain
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Hepatobiliary disorders
Biliary dilatation
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
11.1%
2/18 • Number of events 2 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Hepatobiliary disorders
Jaundice
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Immune system disorders
Hypersensitivity
|
5.6%
1/18 • Number of events 3 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Infections and infestations
Adenovirus infection
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Infections and infestations
COVID-19
|
11.1%
2/18 • Number of events 2 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Infections and infestations
Gastroenteritis viral
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
1/18 • Number of events 3 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
1/18 • Number of events 3 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Infections and infestations
Urinary tract infection
|
11.1%
2/18 • Number of events 2 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Infections and infestations
Urinary tract infection bacterial
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Injury, poisoning and procedural complications
Administration related reaction
|
5.6%
1/18 • Number of events 2 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
3/18 • Number of events 4 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.6%
1/18 • Number of events 2 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Injury, poisoning and procedural complications
Post vaccination syndrome
|
11.1%
2/18 • Number of events 4 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Injury, poisoning and procedural complications
Underdose
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Investigations
Reticulocyte count increased
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Investigations
White blood cell count decreased
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
3/18 • Number of events 4 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • Number of events 2 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Nervous system disorders
Headache
|
27.8%
5/18 • Number of events 9 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Nervous system disorders
Migraine
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Renal and urinary disorders
Dysuria
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Renal and urinary disorders
Hydronephrosis
|
5.6%
1/18 • Number of events 2 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Renal and urinary disorders
Ureterolithiasis
|
5.6%
1/18 • Number of events 2 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
1/18 • Number of events 2 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
5.6%
1/18 • Number of events 4 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
3/18 • Number of events 10 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
5.6%
1/18 • Number of events 2 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.6%
1/18 • Number of events 1 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Vascular disorders
Hot flush
|
5.6%
1/18 • Number of events 2 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
|
Vascular disorders
Hypertension
|
11.1%
2/18 • Number of events 3 • Up to 108 weeks
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening were not considered adverse events for this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI shall have the right to publish or present their own data resulting from the Study ("Publication") upon the earlier of: (a) the date following a multicenter publication coordinated by Sponsor regarding the Protocol; (b) 12 months after completion of the Protocol by all sites; or (c) the date after submission of the Study Data by Sponsor to the FDA. The PI must furnish Sponsor with a copy of any Publication at least 30 days in advance of the proposed submission or presentation date.
- Publication restrictions are in place
Restriction type: OTHER