Trial Outcomes & Findings for An Open-label Study of the Effect of Tomivosertib (eFT508) in Patients With Advanced Castrate-resistant Prostate Cancer (NCT NCT03690141)
NCT ID: NCT03690141
Last Updated: 2024-06-21
Results Overview
* A ≥50% PSA decline from baseline at any time point after therapy and maintained for ≥4 weeks * Objective response according to iRECIST 1.1
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
52 weeks
Results posted on
2024-06-21
Participant Flow
This Phase 2 study examined the efficacy, safety, tolerability, and pharmacokinetics (PK) of tomivosertib in advanced castrate-resistant prostate cancer (CRPC) patients who had documented prostate-specific antigen (PSA) progression on treatment with apalutamide, and/or abiraterone, and/or enzalutamide for whom no suitable curative therapy existed. Study initiation date is 27 November 2018. On 26 June 2019 the study was terminated due to lack of efficacy.
Participant milestones
| Measure |
Tomivosertib (eFT508) 200 mg Twice Daily
Tomivosertib (eFT508) is a novel small-molecule, investigational drug being developed by eFFECTOR Therapeutics, Inc. as an anticancer therapy. Tomivosertib (eFT508) down regulates AR and acts by inhibiting mitogen-activated protein kinase-interacting serine/threonine kinase-1 (MNK1) and MNK2.
tomivosertib (eFT508): This Phase 2 study examines the efficacy, safety, tolerability, and PK of tomivosertib (eFT508) in advanced CRPC patients who have documented PSA progression on treatment with apalutamide and/or abiraterone and/or enzalutamide and for whom no suitable curative therapy exists.
Study drug was administered in 4-week (28-day) treatment cycles. Patients self-administered tomivosertib orally at 200 mg twice daily.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Tomivosertib (eFT508) 200 mg Twice Daily
Tomivosertib (eFT508) is a novel small-molecule, investigational drug being developed by eFFECTOR Therapeutics, Inc. as an anticancer therapy. Tomivosertib (eFT508) down regulates AR and acts by inhibiting mitogen-activated protein kinase-interacting serine/threonine kinase-1 (MNK1) and MNK2.
tomivosertib (eFT508): This Phase 2 study examines the efficacy, safety, tolerability, and PK of tomivosertib (eFT508) in advanced CRPC patients who have documented PSA progression on treatment with apalutamide and/or abiraterone and/or enzalutamide and for whom no suitable curative therapy exists.
Study drug was administered in 4-week (28-day) treatment cycles. Patients self-administered tomivosertib orally at 200 mg twice daily.
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|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Disease progression
|
4
|
Baseline Characteristics
An Open-label Study of the Effect of Tomivosertib (eFT508) in Patients With Advanced Castrate-resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Tomivosertib (eFT508) 200 mg Twice Daily
n=16 Participants
Tomivosertib (eFT508) is a novel small-molecule, investigational drug being developed by eFFECTOR Therapeutics, Inc. as an anticancer therapy. Tomivosertib (eFT508) down regulates AR and acts by inhibiting mitogen-activated protein kinase-interacting serine/threonine kinase-1 (MNK1) and MNK2.
tomivosertib (eFT508): This Phase 2 study examines the efficacy, safety, tolerability, and PK of tomivosertib (eFT508) in advanced CRPC patients who have documented PSA progression on treatment with apalutamide and/or abiraterone and/or enzalutamide and for whom no suitable curative therapy exists.
Study drug was administered in 4-week (28-day) treatment cycles. Patients self-administered tomivosertib orally at 200 mg twice daily.
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|---|---|
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Age, Continuous
|
67.5 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
13 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: A total of 16 participants were enrolled to receive tomivosertib 200 mg. These 16 participants make up the Safety Population (i.e. any participant whom received ≥1 dose of eFT508).
* A ≥50% PSA decline from baseline at any time point after therapy and maintained for ≥4 weeks * Objective response according to iRECIST 1.1
Outcome measures
| Measure |
Tomivosertib (eFT508) 200 mg Twice Daily
n=16 Participants
Tomivosertib (eFT508) is a novel small-molecule, investigational drug being developed by eFFECTOR Therapeutics, Inc. as an anticancer therapy. Tomivosertib (eFT508) down regulates AR and acts by inhibiting mitogen-activated protein kinase-interacting serine/threonine kinase-1 (MNK1) and MNK2.
tomivosertib (eFT508): This Phase 2 study examines the efficacy, safety, tolerability, and PK of tomivosertib (eFT508) in advanced CRPC patients who have documented PSA progression on treatment with apalutamide and/or abiraterone and/or enzalutamide and for whom no suitable curative therapy exists.
Study drug was administered in 4-week (28-day) treatment cycles. Patients self-administered tomivosertib orally at 200 mg twice daily.
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|---|---|
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Anti-tumor Response as Defined by a Patient Achieving Either of the Following Outcomes:
|
0 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPSA progression is defined as a ≥25% increase in PSA from nadir or baseline (and by ≥2 ng/mL) and requires confirmation ≥3 weeks later.
Outcome measures
| Measure |
Tomivosertib (eFT508) 200 mg Twice Daily
n=16 Participants
Tomivosertib (eFT508) is a novel small-molecule, investigational drug being developed by eFFECTOR Therapeutics, Inc. as an anticancer therapy. Tomivosertib (eFT508) down regulates AR and acts by inhibiting mitogen-activated protein kinase-interacting serine/threonine kinase-1 (MNK1) and MNK2.
tomivosertib (eFT508): This Phase 2 study examines the efficacy, safety, tolerability, and PK of tomivosertib (eFT508) in advanced CRPC patients who have documented PSA progression on treatment with apalutamide and/or abiraterone and/or enzalutamide and for whom no suitable curative therapy exists.
Study drug was administered in 4-week (28-day) treatment cycles. Patients self-administered tomivosertib orally at 200 mg twice daily.
|
|---|---|
|
PSA Progression-free Survival From Start of Study Therapy Until the Date PSA Progression is First Observed.
|
8.1 Weeks
Interval 4.1 to 31.1
|
Adverse Events
Tomivosertib (eFT508) 200 mg Twice Daily
Serious events: 7 serious events
Other events: 16 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Tomivosertib (eFT508) 200 mg Twice Daily
n=16 participants at risk
Tomivosertib (eFT508) is a novel small-molecule, investigational drug being developed by eFFECTOR Therapeutics, Inc. as an anticancer therapy. Tomivosertib (eFT508) down regulates AR and acts by inhibiting mitogen-activated protein kinase-interacting serine/threonine kinase-1 (MNK1) and MNK2.
tomivosertib (eFT508): This Phase 2 study examines the efficacy, safety, tolerability, and PK of tomivosertib (eFT508) in advanced CRPC patients who have documented PSA progression on treatment with apalutamide and/or abiraterone and/or enzalutamide and for whom no suitable curative therapy exists.
Study drug was administered in 4-week (28-day) treatment cycles. Patients self-administered tomivosertib orally at 200 mg twice daily.
|
|---|---|
|
General disorders
Chest Pain
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
General disorders
Death
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
General disorders
Disease progression
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Infections and infestations
Bronchitis
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Infections and infestations
Pneumonia
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Infections and infestations
Urosepsis
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Renal and urinary disorders
Haematuria
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Renal and urinary disorders
Obstructive Nephropathy
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Renal and urinary disorders
Urinary bladder rupture
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Gastrointestinal disorders
Diverticulum
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Injury, poisoning and procedural complications
Urinary tract stoma complication
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Nervous system disorders
Seizure
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
Other adverse events
| Measure |
Tomivosertib (eFT508) 200 mg Twice Daily
n=16 participants at risk
Tomivosertib (eFT508) is a novel small-molecule, investigational drug being developed by eFFECTOR Therapeutics, Inc. as an anticancer therapy. Tomivosertib (eFT508) down regulates AR and acts by inhibiting mitogen-activated protein kinase-interacting serine/threonine kinase-1 (MNK1) and MNK2.
tomivosertib (eFT508): This Phase 2 study examines the efficacy, safety, tolerability, and PK of tomivosertib (eFT508) in advanced CRPC patients who have documented PSA progression on treatment with apalutamide and/or abiraterone and/or enzalutamide and for whom no suitable curative therapy exists.
Study drug was administered in 4-week (28-day) treatment cycles. Patients self-administered tomivosertib orally at 200 mg twice daily.
|
|---|---|
|
Nervous system disorders
Poor quality sleep
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Nervous system disorders
Seizure
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Gastrointestinal disorders
nausea
|
43.8%
7/16 • Number of events 7 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Gastrointestinal disorders
Vomiting
|
31.2%
5/16 • Number of events 5 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
4/16 • Number of events 4 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
4/16 • Number of events 4 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
12.5%
2/16 • Number of events 2 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
12.5%
2/16 • Number of events 2 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.8%
3/16 • Number of events 3 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
18.8%
3/16 • Number of events 3 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
2/16 • Number of events 2 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.5%
2/16 • Number of events 2 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
General disorders
Fatigue
|
25.0%
4/16 • Number of events 4 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
General disorders
Edema peripheral
|
12.5%
2/16 • Number of events 2 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Nervous system disorders
Tremor
|
25.0%
4/16 • Number of events 4 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
2/16 • Number of events 2 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Investigations
Blood creatine phosphokinase increased
|
12.5%
2/16 • Number of events 2 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.8%
3/16 • Number of events 3 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Blood and lymphatic system disorders
Anemia
|
18.8%
3/16 • Number of events 3 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
2/16 • Number of events 2 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Renal and urinary disorders
Hematuria
|
12.5%
2/16 • Number of events 2 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Gastrointestinal disorders
Diverticulum
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Gastrointestinal disorders
Gastritis
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Gastrointestinal disorders
Oesophagitis
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
General disorders
Chest pain
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
General disorders
Death
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
General disorders
Disease progression
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
General disorders
Non-cardiac chest pain
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
General disorders
Pain
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Nervous system disorders
Ataxia
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Nervous system disorders
Balance disorder
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Nervous system disorders
Dysarthria
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Infections and infestations
Bronchitis
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Infections and infestations
Influenza
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Infections and infestations
Pneumonia
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Infections and infestations
Pyelonephritis
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Infections and infestations
Urosepsis
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Investigations
Aspartate aminotransferase increase
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Investigations
Haemoglobin decreased
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Investigations
Platelet count decreased
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Investigations
Weight decreased
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Psychiatric disorders
Depression
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Injury, poisoning and procedural complications
Urinary tract stoma complication
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Renal and urinary disorders
Chronic kidney disease
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Renal and urinary disorders
Obstructive nephropathy
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Renal and urinary disorders
Urinary bladder rupture
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
|
Cardiac disorders
Tachycardia
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
|
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Reproductive system and breast disorders
Oedema genital
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6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
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Vascular disorders
Flushing
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6.2%
1/16 • Number of events 1 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, with a mean duration of study drug treatment of 11.5 weeks per participant. All-Cause Mortality was assessed through study completion, up to 52 weeks.
An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not related to the investigational medicinal product.
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Additional Information
Mark Densel, Vice President Development Operations
Effector Therapeutics
Phone: 8589258215
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication or presentation of the results of this study may only be made in compliance with the provisions outlined in the executed Clinical Trial Agreement. Publication of scientific and clinical data will follow the recommendations of the International Committee of Medical Journal Editors, the Consolidated Standards of Reporting Trials group, and Good Publication Practice.
- Publication restrictions are in place
Restriction type: OTHER