Trial Outcomes & Findings for Oral ONC201 in Relapsed/Refractory Multiple Myeloma (NCT NCT02863991)
NCT ID: NCT02863991
Last Updated: 2024-07-03
Results Overview
Assessments of response were made using the International Myeloma Working Group (IMWG) response criteria and were assessed by magnetic resonance imaging (MRI), computed tomography (CT), or positron emission tomography (PET)/CT scans (when applicable). Per IMWG response criteria, objective response could be defined as follows: complete response (CR), disappearance of any soft tissue plasmacytomas; partial response (PR), a \>50% reduction in size of soft tissue plasmacytomas; progressive disease (PD), definite development of new or a definite increase of size of existing soft tissue plasmacytomas; and stable disease (SD), not meeting criteria for CR, PR, or PD.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
17 participants
Primary outcome timeframe
The response assessment data reported was conducted at the last on-study visit (end of treatment/follow-up), up to a maximum of 7 months following treatment initiation.
Results posted on
2024-07-03
Participant Flow
Participant milestones
| Measure |
Phase 1: 375 mg ONC201 + 20 mg Dexamethasone
Patients received 375 mg ONC201 once every week in combination with 20 mg dexamethasone.
|
Phase 2: 625 mg ONC201 + 20 mg Dexamethasone
Patients received 625 mg ONC201 once every week in combination with 20 mg dexamethasone.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
15
|
|
Overall Study
COMPLETED
|
0
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
12
|
Reasons for withdrawal
| Measure |
Phase 1: 375 mg ONC201 + 20 mg Dexamethasone
Patients received 375 mg ONC201 once every week in combination with 20 mg dexamethasone.
|
Phase 2: 625 mg ONC201 + 20 mg Dexamethasone
Patients received 625 mg ONC201 once every week in combination with 20 mg dexamethasone.
|
|---|---|---|
|
Overall Study
Death
|
0
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Study Terminated
|
2
|
8
|
Baseline Characteristics
Oral ONC201 in Relapsed/Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Phase 1: 375 mg ONC201 + 20 mg Dexamethasone
n=2 Participants
Participants received 375 mg ONC201 once weekly in combination with 20 mg dexamethasone.
|
Phase 2: 625 mg ONC201 + 20 mg Dexamethasone
n=15 Participants
Participants received 625 mg ONC201 once weekly in combination with 20 mg dexamethasone.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Number of participants who were not a candidate for established therapy
|
2 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The response assessment data reported was conducted at the last on-study visit (end of treatment/follow-up), up to a maximum of 7 months following treatment initiation.Assessments of response were made using the International Myeloma Working Group (IMWG) response criteria and were assessed by magnetic resonance imaging (MRI), computed tomography (CT), or positron emission tomography (PET)/CT scans (when applicable). Per IMWG response criteria, objective response could be defined as follows: complete response (CR), disappearance of any soft tissue plasmacytomas; partial response (PR), a \>50% reduction in size of soft tissue plasmacytomas; progressive disease (PD), definite development of new or a definite increase of size of existing soft tissue plasmacytomas; and stable disease (SD), not meeting criteria for CR, PR, or PD.
Outcome measures
| Measure |
Phase 1: 375 mg ONC201 + 20 mg Dexamethasone
n=2 Participants
Participants received 375 mg ONC201 once weekly in combination with 20 mg dexamethasone.
|
Phase 2: 625 mg ONC201 + 20 mg Dexamethasone
n=15 Participants
Participants received 625 mg ONC201 once weekly in combination with 20 mg dexamethasone.
|
|---|---|---|
|
Response of Participants at Last On-study Visit (End of Treatment/Follow-up)
Stable disease
|
1 Participants
|
2 Participants
|
|
Response of Participants at Last On-study Visit (End of Treatment/Follow-up)
Progressive disease
|
1 Participants
|
13 Participants
|
Adverse Events
Phase 1: 375 mg ONC201 + 20 mg Dexamethasone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase 2: 625 mg ONC201 + 20 mg Dexamethasone
Serious events: 5 serious events
Other events: 15 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Phase 1: 375 mg ONC201 + 20 mg Dexamethasone
n=2 participants at risk
Participants received 375 mg ONC201 once weekly in combination with 20 mg dexamethasone.
|
Phase 2: 625 mg ONC201 + 20 mg Dexamethasone
n=15 participants at risk
Participants received 625 mg ONC201 once weekly in combination with 20 mg dexamethasone.
|
|---|---|---|
|
General disorders
Disease progression
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Cardiac disorders
Anaemia
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
Other adverse events
| Measure |
Phase 1: 375 mg ONC201 + 20 mg Dexamethasone
n=2 participants at risk
Participants received 375 mg ONC201 once weekly in combination with 20 mg dexamethasone.
|
Phase 2: 625 mg ONC201 + 20 mg Dexamethasone
n=15 participants at risk
Participants received 625 mg ONC201 once weekly in combination with 20 mg dexamethasone.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
86.7%
13/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
60.0%
9/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
26.7%
4/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
46.7%
7/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
53.3%
8/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Eye disorders
Vision blurred
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Gastrointestinal disorders
Abdominal distention
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
13.3%
2/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
33.3%
5/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
20.0%
3/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
General disorders
Asthenia
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
General disorders
Chest pain
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
General disorders
Disease progression
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
General disorders
Fatigue
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
73.3%
11/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
General disorders
Oedema
|
50.0%
1/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
26.7%
4/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
General disorders
Pain
|
100.0%
2/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
0.00%
0/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
General disorders
Swelling face
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
13.3%
2/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Investigations
Carbon dioxide increased
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Investigations
Weight decreased
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
13.3%
2/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Investigations
Weight increased
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
20.0%
3/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Investigations
White blood cell count increased
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
26.7%
4/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
13.3%
2/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
13.3%
2/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
40.0%
6/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
100.0%
2/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
26.7%
4/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
50.0%
1/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
40.0%
6/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
20.0%
3/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Nervous system disorders
Neuropathy peripheral
|
50.0%
1/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
66.7%
10/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
20.0%
3/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Vascular disorders
Hypertension
|
50.0%
1/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
6.7%
1/15 • From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Within 12 months of the completion of the Study at all sites, if no publication of the overall multi-center results has been made, institutions are entitled to publish their locally obtained results, provided the Sponsor is given the opportunity to review and comment. Institution publications may be delayed up to an additional 60 days to allow Sponsor to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER