Trial Outcomes & Findings for A Study of Itacitinib for the Treatment of Chronic Graft Versus Host Disease (cGVHD) (NCT NCT04200365)
NCT ID: NCT04200365
Last Updated: 2024-11-06
Results Overview
Defined as the rate of participants with a cGVHD response of complete response (CR) or partial response (PR) after 6 months of treatment with Itacitinib as defined by 2014 National Institutes of Health Consensus Development Project on Clinical Trials in cGVHD. CR is defined as resolution of all manifestations of cGVHD in each organ or site. PR is defined as the improvement in at least one organ or site without progression in any other organ or site.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Response assessed Day 1 of every cycle up until the end of treatment, up to 24 months. This outcome measure is the ORR for all patients once they have been on treatment for 6 months.
Results posted on
2024-11-06
Participant Flow
Participant milestones
| Measure |
Itacitinib
Itacitinib: Itacitinib will be administered orally once daily for up to 24 months.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Itacitinib
Itacitinib: Itacitinib will be administered orally once daily for up to 24 months.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Progressive Disease
|
4
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Study Closure
|
4
|
Baseline Characteristics
A Study of Itacitinib for the Treatment of Chronic Graft Versus Host Disease (cGVHD)
Baseline characteristics by cohort
| Measure |
Itacitinib
n=15 Participants
Itacitinib: Participants received itacitinib orally once daily for up to 24 months.
|
|---|---|
|
Age, Continuous
|
59.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Response assessed Day 1 of every cycle up until the end of treatment, up to 24 months. This outcome measure is the ORR for all patients once they have been on treatment for 6 months.Population: Participants must have had one dose of study drug and must have had 1 post-baseline disease evaluation.
Defined as the rate of participants with a cGVHD response of complete response (CR) or partial response (PR) after 6 months of treatment with Itacitinib as defined by 2014 National Institutes of Health Consensus Development Project on Clinical Trials in cGVHD. CR is defined as resolution of all manifestations of cGVHD in each organ or site. PR is defined as the improvement in at least one organ or site without progression in any other organ or site.
Outcome measures
| Measure |
Itacitinib
n=15 Participants
Itacitinib: Itacitinib will be administered orally once daily for up to 24 months.
|
|---|---|
|
cGVHD Overall Response Rate (ORR) at 6 Months on Treatment
|
93 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of itacitinib until end of study treatment, up to 24 monthsPopulation: Participants must have had one dose of study drug
Ability to withdraw or decrease steroids to ˂0.5 mg/kg of methylprednisolone or equivalent
Outcome measures
| Measure |
Itacitinib
n=15 Participants
Itacitinib: Itacitinib will be administered orally once daily for up to 24 months.
|
|---|---|
|
Number of Participants That Can Withdraw or Decrease Steroids
|
9 Participants
|
SECONDARY outcome
Timeframe: Every 3 months for 1 year after last dose of study treatment, up to 29 months.Population: Participants must have had one dose of study drug and must have had 1 post-baseline disease evaluation.
Overall Survival (OS) is defined as the time from the first day of study drug administration (Day 1) to death on study. Patients who are alive will be censored at the date of last known date alive.
Outcome measures
| Measure |
Itacitinib
n=15 Participants
Itacitinib: Itacitinib will be administered orally once daily for up to 24 months.
|
|---|---|
|
Overall Survival
|
NA months
Interval 15.5 to
The median and upper limit of the 95% CI are not estimable by Kaplan-Meier method based on the data and events collected due to an insufficient number of participants with death events.
|
SECONDARY outcome
Timeframe: Safety will be assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months.Population: Participants must have had one dose of study drug
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
Outcome measures
| Measure |
Itacitinib
n=15 Participants
Itacitinib: Itacitinib will be administered orally once daily for up to 24 months.
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability of Itacitinib
|
15 Participants
|
SECONDARY outcome
Timeframe: Quality of life will be assessed prior during screening and end of treatment, up to 24 months of treatment. Participants showing improvement in LSS score from Screening to End of Treatment are shown here.Population: Participants must have had one dose of study drug and must have had 1 post-baseline disease evaluation.
Changes in symptom burden will be measured using the Lee Symptom Scale. Subscale scores and the summary score range from 0 to 100, with a higher score indicating worse symptoms.
Outcome measures
| Measure |
Itacitinib
n=15 Participants
Itacitinib: Itacitinib will be administered orally once daily for up to 24 months.
|
|---|---|
|
Number of Participants With Improvement in Quality of Life Per the Lee Symptom Scale
|
11 Participants
|
SECONDARY outcome
Timeframe: cGVHD status will be assessed at cycle 1 day 1, day 1 of every cycle and at the end of treatment, up to 24 monthsPopulation: Participants must have had one dose of study drug and must have had 1 post-baseline disease evaluation.
Participants will be assessed for severity of cGVHD using the Clinician-Reported Global cGVHD Activity Assessment Form and Patient-reported cGVHD Activity Assessment Form. Progression in at least one organ or site without a response in any other organ or site per NIH 2014 Consensus Development Project on Clinical Trials in cGVHD.
Outcome measures
| Measure |
Itacitinib
n=15 Participants
Itacitinib: Itacitinib will be administered orally once daily for up to 24 months.
|
|---|---|
|
Number of Participants With Recurrence or Progression of cGVHD
|
5 Participants
|
SECONDARY outcome
Timeframe: Relapse of underlying malignancy will be assessed on Day 1 of each cycle, at end of treatment and survival follow-up. Follow-up visits every 3 months for 1 year after last dose of study treatment, up to 29 monthsPopulation: Participants must have had one dose of study drug and must have had 1 post-baseline disease evaluation.
Participants will be closely monitored for any evidence of underlying disease relapse or recurrence. Formal re-staging will be done at physician discretion.
Outcome measures
| Measure |
Itacitinib
n=15 Participants
Itacitinib: Itacitinib will be administered orally once daily for up to 24 months.
|
|---|---|
|
Relapse Rate of Underlying Malignancy
|
2 participants
|
Adverse Events
Itacitinib
Serious events: 6 serious events
Other events: 15 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Itacitinib
n=15 participants at risk
Itacitinib: Participants received itacitinib orally once daily for up to 24 months.
|
|---|---|
|
Injury, poisoning and procedural complications
Brain contusion
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Infections and infestations
Cellulitis
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Infections and infestations
Device related infection
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Vascular disorders
Embolism
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Injury, poisoning and procedural complications
Eye contusion
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
General disorders
Pneumatosis
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Infections and infestations
Respiratory tract infection bacterial
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
Other adverse events
| Measure |
Itacitinib
n=15 participants at risk
Itacitinib: Participants received itacitinib orally once daily for up to 24 months.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
3/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Ear and labyrinth disorders
Balance disorder
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Ear and labyrinth disorders
Ear pain
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Ear and labyrinth disorders
Tinnitus
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Endocrine disorders
Adrenal insufficiency
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Eye disorders
Cataract
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Eye disorders
Cataract operation
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Eye disorders
Conjunctival haemorrhage
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Eye disorders
Dry eye
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Eye disorders
Vision blurred
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Gastrointestinal disorders
Abdominal tenderness
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Gastrointestinal disorders
Colitis
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Gastrointestinal disorders
Constipation
|
20.0%
3/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Gastrointestinal disorders
Dental caries
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Gastrointestinal disorders
Diarrhoea
|
26.7%
4/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Gastrointestinal disorders
Dry mouth
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Gastrointestinal disorders
Lip swelling
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Gastrointestinal disorders
Nausea
|
26.7%
4/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
General disorders
Asthenia
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
General disorders
Chest pain
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
General disorders
Chills
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
General disorders
Fatigue
|
26.7%
4/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
General disorders
Generalised oedema
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
General disorders
Localised oedema
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
General disorders
Malaise
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
General disorders
Oedema peripheral
|
20.0%
3/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
General disorders
Pain
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
General disorders
Pyrexia
|
26.7%
4/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Immune system disorders
Angioedema
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Infections and infestations
Candida infection
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Infections and infestations
Cellulitis
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Infections and infestations
COVID-19
|
20.0%
3/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Infections and infestations
Epstein-Barr virus infection reactivation
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Infections and infestations
Food poisoning
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Infections and infestations
Gram stain positive
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Infections and infestations
Polyomavirus viraemia
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Injury, poisoning and procedural complications
Contusion
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
3/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Injury, poisoning and procedural complications
Skin wound
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Injury, poisoning and procedural complications
Wound
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
3/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Investigations
Aspartate aminotransferase increased
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Investigations
Blood alkaline phosphatase increased
|
20.0%
3/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Investigations
Blood cholesterol increased
|
20.0%
3/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Investigations
Blood creatinine increased
|
33.3%
5/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Investigations
Blood lactate dehydrogenase increased
|
20.0%
3/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Investigations
Blood lactic acid increased
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Investigations
Blood triglycerides increased
|
20.0%
3/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Investigations
Blood urea increased
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Investigations
Electrocardiogram QT prolonged
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Investigations
Low density lipoprotein increased
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Investigations
Lymphocyte count decreased
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Investigations
Monocyte count increased
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Investigations
Neutrophil count increased
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Investigations
Platelet count decreased
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Investigations
Platelet count increased
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Investigations
Weight increased
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Investigations
White blood cell count decreased
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Investigations
White blood cell count increased
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Metabolism and nutrition disorders
Acidosis
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
5/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Metabolism and nutrition disorders
Hypertransaminasaemia
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Metabolism and nutrition disorders
Hypoaesthesia
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
20.0%
3/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
3/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
3/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Musculoskeletal and connective tissue disorders
Physical deconditioning
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Musculoskeletal and connective tissue disorders
Soft tissue disorder
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Nervous system disorders
Dizziness
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Nervous system disorders
Headache
|
26.7%
4/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Nervous system disorders
Memory impairment
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Nervous system disorders
Orthostatic hypotension
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Nervous system disorders
Paraesthesia
|
20.0%
3/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Nervous system disorders
Restless legs syndrome
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Nervous system disorders
Tremor
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Psychiatric disorders
Depression
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Psychiatric disorders
Insomnia
|
20.0%
3/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Renal and urinary disorders
Dysuria
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Renal and urinary disorders
Haematuria
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Renal and urinary disorders
Pollakiuria
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Renal and urinary disorders
Renal impairment
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Renal and urinary disorders
Urinary retention
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Renal and urinary disorders
Urinary tract infection
|
20.0%
3/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Reproductive system and breast disorders
Hypoxia
|
20.0%
3/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Reproductive system and breast disorders
Penile discomfort
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Reproductive system and breast disorders
Vulval ulceration
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.7%
4/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Skin and subcutaneous tissue disorders
Skin laceration
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Social circumstances
Alcohol abuse
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Vascular disorders
Bleeding varicose vein
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Vascular disorders
Deep vein thrombosis
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Vascular disorders
Embolism
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Vascular disorders
Haematoma
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Vascular disorders
Hypertension
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Vascular disorders
Hypotension
|
13.3%
2/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
|
Vascular disorders
Thrombosis
|
6.7%
1/15 • Adverse events were assessed from the time that informed consent is signed until 30 days after the last dose of study treatment, up to 25 months. All-Cause Mortality was assessed up to 29 months.
Adverse events will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0)
|
Additional Information
Sarah Cannon Development Innovations, LLC
Sarah Cannon Development Innovations, LLC
Phone: 844-710-6157
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place