Trial Outcomes & Findings for Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas (NCT NCT03598998)
NCT ID: NCT03598998
Last Updated: 2025-06-26
Results Overview
Dose limiting toxicities (DLT) were defined as one of the AEs in Protocol Section 5.5 that at least possibly related to study treatment. The DLT observation period was 2 cycles of therapy, from the start of Cycle 1 through the start of Cycle 3. Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
13 participants
Primary outcome timeframe
From the start of Cycle 1 through the start of Cycle 3 (approximately 42 days)
Results posted on
2025-06-26
Participant Flow
Due to low/slow accrual, this study was permanently closed to accrual after enrolling 13 patients in Phase I, with no accrual in Phase II. Of the 13 patients in Phase I, 7 were at dose level 1 and 6 were at dose level 2.
Participant milestones
| Measure |
Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2
Patients receive pralatrexate 20mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2
Patients receive pralatrexate 30mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas
Baseline characteristics by cohort
| Measure |
Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2
n=7 Participants
Patients receive pralatrexate 20mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2
n=6 Participants
Patients receive pralatrexate 30mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
68 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
6 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
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 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
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the start of Cycle 1 through the start of Cycle 3 (approximately 42 days)Population: Two patients in dose level 1 and one patient in dose level 2 were not evaluable for DLT.
Dose limiting toxicities (DLT) were defined as one of the AEs in Protocol Section 5.5 that at least possibly related to study treatment. The DLT observation period was 2 cycles of therapy, from the start of Cycle 1 through the start of Cycle 3. Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Outcome measures
| Measure |
Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2
n=5 Participants
Patients receive pralatrexate 20mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2
n=5 Participants
Patients receive pralatrexate 30mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants Who Had Dose Limiting Toxicities
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 43 months after the initial study treatment.Number of participants who had a documented complete response (CR) or partial response (PR) at any time during study treatment. Disease response/progression by PET-CT or CT was evaluated using 2014 Lugano Classification.
Outcome measures
| Measure |
Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2
n=7 Participants
Patients receive pralatrexate 20mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2
n=6 Participants
Patients receive pralatrexate 30mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants Who Had Overall Response
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 43 months after the initial study treatment.Number of participants who had a documented complete response at any time during study treatment. Disease response/progression by PET-CT or CT was evaluated using 2014 Lugano Classification.
Outcome measures
| Measure |
Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2
n=7 Participants
Patients receive pralatrexate 20mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2
n=6 Participants
Patients receive pralatrexate 30mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants Who Had Complete Response (CR)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From the start time of the initial treatment assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months).Number of Participants who had grade 3 4 5 toxicities at lease possibly related to study treatment. Toxicities were assessed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade refers to the severity of the AE and ranges from 1 to 5 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death).
Outcome measures
| Measure |
Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2
n=7 Participants
Patients receive pralatrexate 20mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2
n=6 Participants
Patients receive pralatrexate 30mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants With Grade 3 4 5 Adverse Events
|
4 participants
|
3 participants
|
Adverse Events
Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2
Serious events: 2 serious events
Other events: 7 other events
Deaths: 5 deaths
Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2
Serious events: 3 serious events
Other events: 6 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2
n=7 participants at risk
Patients receive pralatrexate 20mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2
n=6 participants at risk
Patients receive pralatrexate 30mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Gastrointestinal disorders
CLOSTRIDIOIDES DIFFICILE
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
General disorders
DISEASE PROGRESSION
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
General disorders
FEVER
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
General disorders
TUMOR FLARE
|
0.00%
0/7 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Infections and infestations
ENCEPHALITIS INFECTION
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Infections and infestations
HERPES SIMPLEX REACTIVATION
|
0.00%
0/7 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Injury, poisoning and procedural complications
VASCULAR ACCESS COMPLICATION
|
0.00%
0/7 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL OBSTRUCTION
|
0.00%
0/7 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/7 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
Other adverse events
| Measure |
Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2
n=7 participants at risk
Patients receive pralatrexate 20mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2
n=6 participants at risk
Patients receive pralatrexate 30mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANEMIA
|
71.4%
5/7 • Number of events 10 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Blood and lymphatic system disorders
EOSINOPHILIA
|
14.3%
1/7 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Blood and lymphatic system disorders
PLATELET COUNT INCREASED
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
14.3%
1/7 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
42.9%
3/7 • Number of events 10 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
33.3%
2/6 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Cardiac disorders
VENTRICULAR ARRHYTHMIA
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Eye disorders
CATARACT
|
0.00%
0/7 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Eye disorders
PERIORBITAL EDEMA
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Gastrointestinal disorders
CONSTIPATION
|
28.6%
2/7 • Number of events 3 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Gastrointestinal disorders
DIARRHEA
|
42.9%
3/7 • Number of events 3 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
50.0%
3/6 • Number of events 3 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Gastrointestinal disorders
DRY MOUTH
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
14.3%
1/7 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
28.6%
2/7 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Gastrointestinal disorders
NAUSEA
|
28.6%
2/7 • Number of events 3 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Gastrointestinal disorders
ORAL PAIN
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Gastrointestinal disorders
VOMITING
|
14.3%
1/7 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
General disorders
CHILLS
|
42.9%
3/7 • Number of events 4 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
General disorders
DISEASE PROGRESSION
|
57.1%
4/7 • Number of events 4 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
33.3%
2/6 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
General disorders
EDEMA FACE
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
General disorders
FACIAL PAIN
|
14.3%
1/7 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
General disorders
FATIGUE
|
57.1%
4/7 • Number of events 5 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
50.0%
3/6 • Number of events 6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
General disorders
FEVER
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
General disorders
GAIT DISTURBANCE
|
14.3%
1/7 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
General disorders
GENERALIZED EDEMA
|
0.00%
0/7 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
General disorders
MALAISE
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
General disorders
NECK EDEMA
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
General disorders
PAIN
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Infections and infestations
RASH PUSTULAR
|
0.00%
0/7 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Injury, poisoning and procedural complications
FALL
|
14.3%
1/7 • Number of events 3 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
33.3%
2/6 • Number of events 4 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
28.6%
2/7 • Number of events 4 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
28.6%
2/7 • Number of events 3 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
28.6%
2/7 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Investigations
CREATININE INCREASED
|
0.00%
0/7 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Investigations
ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
57.1%
4/7 • Number of events 4 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
28.6%
2/7 • Number of events 6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 4 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Investigations
PLATELET COUNT DECREASED
|
71.4%
5/7 • Number of events 18 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 3 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Investigations
WEIGHT LOSS
|
28.6%
2/7 • Number of events 6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
42.9%
3/7 • Number of events 7 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
28.6%
2/7 • Number of events 4 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
50.0%
3/6 • Number of events 3 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
33.3%
2/6 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
0.00%
0/7 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
42.9%
3/7 • Number of events 7 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
33.3%
2/6 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Metabolism and nutrition disorders
HYPERPHOSPHATEMIA
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
57.1%
4/7 • Number of events 11 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
28.6%
2/7 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
33.3%
2/6 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
28.6%
2/7 • Number of events 4 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
57.1%
4/7 • Number of events 6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
71.4%
5/7 • Number of events 5 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
57.1%
4/7 • Number of events 13 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
0.00%
0/7 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Metabolism and nutrition disorders
OBESITY
|
14.3%
1/7 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
14.3%
1/7 • Number of events 4 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Musculoskeletal and connective tissue disorders
HEAD SOFT TISSUE NECROSIS
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE CRAMP
|
0.00%
0/7 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ANAPLASTIC ASTROCYTOMA
|
0.00%
0/7 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Nervous system disorders
DIZZINESS
|
14.3%
1/7 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Nervous system disorders
DYSARTHRIA
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/7 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
33.3%
2/6 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/7 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Nervous system disorders
HYDROCEPHALUS
|
0.00%
0/7 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Nervous system disorders
HYPERSOMNIA
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Nervous system disorders
NEURALGIA
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Psychiatric disorders
ANXIETY
|
14.3%
1/7 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Psychiatric disorders
CONFUSION
|
14.3%
1/7 • Number of events 4 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Psychiatric disorders
DEPRESSION
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Psychiatric disorders
HALLUCINATIONS
|
0.00%
0/7 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/7 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
33.3%
2/6 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
14.3%
1/7 • Number of events 3 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/7 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
HOARSENESS
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/7 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
VOICE ALTERATION
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Skin and subcutaneous tissue disorders
BULLOUS DERMATITIS
|
0.00%
0/7 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/7 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Skin and subcutaneous tissue disorders
HYPERKERATOSIS
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
42.9%
3/7 • Number of events 3 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
14.3%
1/7 • Number of events 1 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Vascular disorders
HYPERTENSION
|
57.1%
4/7 • Number of events 32 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
16.7%
1/6 • Number of events 5 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
|
Vascular disorders
HYPOTENSION
|
28.6%
2/7 • Number of events 2 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
0.00%
0/6 • Adverse Events were assessed through 8 treatment cycles (21 days per cycle) up to 90 days from last dose (approximately 9 months). All-Cause Mortality was monitored/assessed up to 43 months from the start time of the initial treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place