Trial Outcomes & Findings for Safety and Efficacy Study of PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (NCT NCT01217229)
NCT ID: NCT01217229
Last Updated: 2020-06-30
Results Overview
Progression-free survival was assessed by Kaplan Meier analysis and was defined as the number of days from the first day of treatment to the date of first documented disease progression or date of death (whichever occurred first).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Baseline to 1 year postdose
Results posted on
2020-06-30
Participant Flow
A total of 20 participants who met all inclusion and no exclusion criteria were enrolled and received treatment at 6 clinic sites in the United States.
Participant milestones
| Measure |
PLX3397
Participants received PLX3397 administered once or twice daily with continuous dosing at 900 mg/day.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
PLX3397
Participants received PLX3397 administered once or twice daily with continuous dosing at 900 mg/day.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Disease progression, deterioration
|
2
|
|
Overall Study
Disease progression, Cheson criteria
|
14
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Disease progression not confirmed
|
2
|
Baseline Characteristics
Safety and Efficacy Study of PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
PLX3397
n=20 Participants
Participants received PLX3397 administered once or twice daily with continuous dosing at 900 mg/day.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 19.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 1 year postdosePopulation: Progression-free survival was assessed in the Modified Intent-to-Treat population.
Progression-free survival was assessed by Kaplan Meier analysis and was defined as the number of days from the first day of treatment to the date of first documented disease progression or date of death (whichever occurred first).
Outcome measures
| Measure |
PLX3397
n=20 Participants
Participants received PLX3397 administered once or twice daily with continuous dosing at 900 mg/day.
|
|---|---|
|
Progression-Free Survival According to the Cheson Criteria by Kaplan-Meier Analysis Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
|
56 days
Interval 54.0 to 57.0
|
PRIMARY outcome
Timeframe: Baseline to Cycles 3, 5, 7, 10, and 13, up to 1 year postdosePopulation: Tumor response was assessed in the Modified Intent-to-Treat population.
Subjects were monitored for response and disease progression with contrast Computed tomography (CT) /18Fluorodeoxyglucose (FDG)-positron emission tomography (PET) scans every two cycles. Each cycle is 28 days. Response to treatment as defined by Cheson criteria was reported via descriptive statistics. Target tumor response is Complete Response (CR) + Partial Response (PR) and target tumor disease control rate (CR + PR + Stable Disease (SD)) are reported. Per Cheson Criteria, CR is disappearance of all evidence of disease; Partial Response is regression of measurable disease and no new sites (≥50% decrease in sum of product diameters of up to 6 largest dominant masses and splenic/liver nodules), and no increase in size of other nodes/liver/spleen; reduction in target lesions, no growth of non-target or new lesions; Progression is any new lesion or increase by ≥50% of previously involved sites from the nadir.
Outcome measures
| Measure |
PLX3397
n=20 Participants
Participants received PLX3397 administered once or twice daily with continuous dosing at 900 mg/day.
|
|---|---|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Overall: Stable disease (SD)
|
3 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 7: Target tumor response (CR+PR)
|
1 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 7: Complete response (CR)
|
0 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 10: Complete response (CR)
|
0 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 13: Target tumor DCR (CR+PR+SD)
|
1 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Overall: Target tumor response (CR+PR)
|
1 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Overall: Target tumor DCR (CR+PR+SD)
|
4 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Overall: Complete response (CR)
|
0 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Overall: Partial response (PR)
|
1 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Overall: Relapsed disease or progressive disease
|
13 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 3: Target tumor response (CR+PR)
|
0 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 3: Target tumor DCR (CR+PR+SD)
|
4 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 3: Complete response (CR)
|
0 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 3: Partial response (PR)
|
0 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 3: Stable disease (SD)
|
4 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 3: Relapsed disease or progressive disease
|
1 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 5: Target tumor response (CR+PR)
|
0 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 5: Target tumor DCR (CR+PR+SD)
|
1 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 5: Complete response (CR)
|
0 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 5: Partial response (PR)
|
0 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 5: Stable disease (SD)
|
1 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 5: Relapsed disease or progressive disease
|
0 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 7: Target tumor DCR (CR+PR+SD)
|
1 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 7: Partial response (PR)
|
1 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 7: Stable disease (SD)
|
0 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 7: Relapsed disease or progressive disease
|
0 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 10: Target tumor response (CR+PR)
|
1 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 10: Target tumor DCR (CR+PR+SD)
|
1 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 10: Partial response (PR)
|
1 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 10: Stable disease (SD)
|
0 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 10: Relapsed disease or progressive disease
|
0 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 13: Target tumor response (CR+PR)
|
1 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 13: Complete response (CR)
|
0 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 13: Partial response (PR)
|
1 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 13: Stable disease (SD)
|
0 Participants
|
|
Summary of Overall Tumor Response and By Cycle Following Orally Administered PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma (Modified Intent-to-Treat Population)
Cycle 13: Relapsed disease or progressive disease
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to 1 year post-dosePopulation: Adverse events were assessed in the Safety Analysis population.
Outcome measures
| Measure |
PLX3397
n=20 Participants
Participants received PLX3397 administered once or twice daily with continuous dosing at 900 mg/day.
|
|---|---|
|
Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)
Chills
|
2 Participants
|
|
Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)
Fatigue
|
8 Participants
|
|
Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)
Rash
|
5 Participants
|
|
Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)
At least 1 adverse event
|
20 Participants
|
|
Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)
Anaemia
|
6 Participants
|
|
Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)
Thrombocytopenia
|
6 Participants
|
|
Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)
Diarrhoea
|
2 Participants
|
|
Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)
Nausea
|
2 Participants
|
|
Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)
Vomiting
|
2 Participants
|
|
Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)
Pyrexia
|
4 Participants
|
|
Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)
Aspartate aminotransferase increased
|
2 Participants
|
|
Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)
Blood lactate dehydrogenase increased
|
5 Participants
|
|
Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)
Decreased appetite
|
3 Participants
|
|
Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)
Back pain
|
2 Participants
|
|
Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)
Dizziness
|
2 Participants
|
|
Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)
Headache
|
2 Participants
|
|
Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)
Cough
|
3 Participants
|
|
Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)
Dyspnoea
|
5 Participants
|
|
Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)
Productive cough
|
2 Participants
|
|
Participants With Treatment-Emergent Adverse Events Occurring at a Frequency of ≥10% in Any Preferred Term (Safety Population)
Hair colour changes
|
8 Participants
|
PRIMARY outcome
Timeframe: Baseline to 1 year postdosePopulation: Adverse events were assessed in the Safety Analysis population.
Grade 2 adverse events were defined as events that were moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL).
Outcome measures
| Measure |
PLX3397
n=20 Participants
Participants received PLX3397 administered once or twice daily with continuous dosing at 900 mg/day.
|
|---|---|
|
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
Grade 3 Thrombocytopenia
|
1 Participants
|
|
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
Grade 2 Fatigue
|
5 Participants
|
|
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
At least 1 Grade 2 adverse event
|
13 Participants
|
|
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
At least 1 Grade 3 adverse event
|
5 Participants
|
|
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
Grade 2 Anaemia
|
6 Participants
|
|
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
Grade 2 Neutropenia
|
1 Participants
|
|
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
Grade 3 Neutropenia
|
1 Participants
|
|
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
Grade 2 Thrombocytopenia
|
1 Participants
|
|
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
Grade 2 Pyrexia
|
2 Participants
|
|
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
Grade 3 Lung infection
|
1 Participants
|
|
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
Grade 2 Pneumonia
|
1 Participants
|
|
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
Grade 3 Blood alkaline phosphatase
|
1 Participants
|
|
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
Grade 2 Blood lactate dehydrogenase increased
|
2 Participants
|
|
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
Grade 3 Neutrophil count decreased
|
3 Participants
|
|
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
Grade 2 Decreased appetite
|
1 Participants
|
|
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
Grade 2 Muscular weakness
|
1 Participants
|
|
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
Grade 2 Squamous cell carcinoma
|
1 Participants
|
|
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
Grade 3 Syncope
|
1 Participants
|
|
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
Grade 2 Anxiety
|
1 Participants
|
|
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
Grade 2 Dyspnoea
|
2 Participants
|
|
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
Grade 2 Erythema multiforme
|
1 Participants
|
|
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
Grade 2 Rash
|
2 Participants
|
|
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
Grade 3 Rash
|
1 Participants
|
|
Participants With at Least Grade 2 Severity Adverse Events by Preferred Term (Safety Population)
Grade 2 Skin exfoliation
|
1 Participants
|
Adverse Events
PLX3397
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PLX3397
n=20 participants at risk
Participants received PLX3397 administered once or twice daily with continuous dosing at 900 mg/day.
|
|---|---|
|
Infections and infestations
Lung infection
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
General disorders
Pyrexia
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
Other adverse events
| Measure |
PLX3397
n=20 participants at risk
Participants received PLX3397 administered once or twice daily with continuous dosing at 900 mg/day.
|
|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.0%
3/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
2/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Nervous system disorders
Balance disorder
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Nervous system disorders
Dysgeusia
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Nervous system disorders
Lethargy
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Nervous system disorders
Syncope
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Nervous system disorders
Tremor
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Psychiatric disorders
Hallucination
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
3/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
5/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Blood and lymphatic system disorders
Anaemia
|
30.0%
6/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
30.0%
6/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
General disorders
Fatigue
|
40.0%
8/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Skin and subcutaneous tissue disorders
Hair depigmentation
|
40.0%
8/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
5/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
5/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Ear and labyrinth disorders
Ear pain
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Eye disorders
Eye swelling
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Eye disorders
Eyelid oedema
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
2/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Gastrointestinal disorders
Asthenia
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Gastrointestinal disorders
Chills
|
10.0%
2/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Gastrointestinal disorders
Face odema
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Gastrointestinal disorders
Fatigue
|
40.0%
8/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Gastrointestinal disorders
Pyrexia
|
20.0%
4/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Infections and infestations
Clostridial infection
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Infections and infestations
Herpes zoster
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Infections and infestations
Lung infection
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Infections and infestations
Pneumonia
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
2/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Investigations
Blood alkaline phosphatase
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Investigations
Blood lactate dehydrogenase increased
|
25.0%
5/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Investigations
Neutrophil count decreased
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.0%
2/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
40.0%
8/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
5.0%
1/20 • Adverse events were collected from study enrollment up to 1 year post dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60