Trial Outcomes & Findings for Cabozantinib and Nivolumab for Carcinoid Tumors (NCT NCT04197310)
NCT ID: NCT04197310
Last Updated: 2025-01-31
Results Overview
ORR is defined by RECIST 1.1 criteria, the percentage of subjects with a confirmed complete response or partial response at any time during treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
46 months
Results posted on
2025-01-31
Participant Flow
Participant milestones
| Measure |
Nivolumab + Cabozantinib
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Cabozantinib will be administered at a dose of 40mg, orally, once daily for a 28 day cycle
* Nivolumab will be given at a dose of 240mg, intravenously, Day 1 and 15 of a 28 day cycle
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cabozantinib and Nivolumab for Carcinoid Tumors
Baseline characteristics by cohort
| Measure |
Nivolumab + Cabozantinib
n=19 Participants
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Cabozantinib will be administered at a dose of 40mg, orally, once daily for a 28 day cycle
* Nivolumab will be given at a dose of 240mg, intravenously, Day 1 and 15 of a 28 day cycle
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 46 monthsORR is defined by RECIST 1.1 criteria, the percentage of subjects with a confirmed complete response or partial response at any time during treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Nivolumab + Cabozantinib
n=19 Participants
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Cabozantinib will be administered at a dose of 40mg, orally, once daily for a 28 day cycle
* Nivolumab will be given at a dose of 240mg, intravenously, Day 1 and 15 of a 28 day cycle
|
|---|---|
|
Objective Response Rate (ORR)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Time from randomization (or registration) to the earlier of progression or death due to any cause. The median survival follow-up time was 5.6 months (range 1.4 - 31.0 months).Progression-Free Survival (PFS) is defined as the time from randomization (or registration) to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesion and/or unequivocal progression of existing non-target lesions are also considered progression. Unequivocal progression should not normally trump target lesion status and must be representative of overall disease status change, not a single lesion increase.
Outcome measures
| Measure |
Nivolumab + Cabozantinib
n=19 Participants
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Cabozantinib will be administered at a dose of 40mg, orally, once daily for a 28 day cycle
* Nivolumab will be given at a dose of 240mg, intravenously, Day 1 and 15 of a 28 day cycle
|
|---|---|
|
Progression-free Survival (PFS)
|
5.6 months
Interval 3.5 to 9.9
|
SECONDARY outcome
Timeframe: 46 monthsPopulation: A total of 17 participants were analyzed for ORR using irRC, with data from 2 participants unavailable for analysis based on this criterion.
ORR will be determined according to immune-related response criteria (irRC). irComplete Response (irCR): Complete disappearance of all target lesions. irPartial Response (irPR): Decrease, relative to baseline, or 50% or greater in the sum of the products of the two largest perpendicular diameters of all target and all new measurable target lesions. irStable Disease (irSD): Does not meet criteria for irRC or irPR, in the absence of progressive disease. irProgressive Disease (irPD): At least 25% increase Percentage Change in Tumor Burden when compared to SPD at nadir.
Outcome measures
| Measure |
Nivolumab + Cabozantinib
n=17 Participants
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Cabozantinib will be administered at a dose of 40mg, orally, once daily for a 28 day cycle
* Nivolumab will be given at a dose of 240mg, intravenously, Day 1 and 15 of a 28 day cycle
|
|---|---|
|
Overall Response Rate (ORR) Per Immune-related Response Criteria
|
0 Participants
|
SECONDARY outcome
Timeframe: Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive. OS was calculated for a median of 6.9 months, ranging from 2.8 - 31.0 months.Kaplan and Meier to assess Overall survival (OS).
Outcome measures
| Measure |
Nivolumab + Cabozantinib
n=19 Participants
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Cabozantinib will be administered at a dose of 40mg, orally, once daily for a 28 day cycle
* Nivolumab will be given at a dose of 240mg, intravenously, Day 1 and 15 of a 28 day cycle
|
|---|---|
|
Overall Survival (OS)
|
16.0 months
Interval 6.5 to
The upper limit of the 95% confidence interval was not detected due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: AEs were reviewed between the initial dose of study treatment and 100 days of the last dose of treatment. AEs were assessed for a median of 8.8 months, ranging from 4.7 - 33.7 months.Safety was assessed by analysis of adverse event (AE) and toxicity data. AE and toxicity data are defined according to NCI CTCAE version 5.0. Adverse Events were reviewed between the initial dose of study treatment and 100 days of the last dose of treatment. All adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv5 as reported on case report forms will be counted. Rate is the proportion of treated participants experiencing at least one treatment-related AE of any type during the time of observation.
Outcome measures
| Measure |
Nivolumab + Cabozantinib
n=19 Participants
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Cabozantinib will be administered at a dose of 40mg, orally, once daily for a 28 day cycle
* Nivolumab will be given at a dose of 240mg, intravenously, Day 1 and 15 of a 28 day cycle
|
|---|---|
|
Number of Participants With Treatment Related Adverse Events
|
19 Participants
|
SECONDARY outcome
Timeframe: The median survival follow-up time was 5.6 months (range 1.4 - 31.0 months).To evaluate duration of response of participants receiving Nivolumab and Cabozatinib. Duration of response was evaluated from date of registration to date of death or last known date alive.
Outcome measures
| Measure |
Nivolumab + Cabozantinib
n=19 Participants
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Cabozantinib will be administered at a dose of 40mg, orally, once daily for a 28 day cycle
* Nivolumab will be given at a dose of 240mg, intravenously, Day 1 and 15 of a 28 day cycle
|
|---|---|
|
Duration of Response
|
NA months
Duration of response was not observed due to a lack of participants with events.
|
Adverse Events
Nivolumab + Cabozantinib
Serious events: 9 serious events
Other events: 19 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Nivolumab + Cabozantinib
n=19 participants at risk
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Cabozantinib will be administered at a dose of 40mg, orally, once daily for a 28 day cycle
* Nivolumab will be given at a dose of 240mg, intravenously, Day 1 and 15 of a 28 day cycle
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
15.8%
3/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Investigations
Alkaline phosphatase increased
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Investigations
Blood bilirubin increased
|
15.8%
3/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Gastrointestinal disorders
Colitis
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Psychiatric disorders
Confusion
|
15.8%
3/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Investigations
Creatinine increased
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Vascular disorders
Hypotension
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Renal and urinary disorders
Renal calculi
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Nervous system disorders
Seizure
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Infections and infestations
Sepsis
|
10.5%
2/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
Other adverse events
| Measure |
Nivolumab + Cabozantinib
n=19 participants at risk
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Cabozantinib will be administered at a dose of 40mg, orally, once daily for a 28 day cycle
* Nivolumab will be given at a dose of 240mg, intravenously, Day 1 and 15 of a 28 day cycle
|
|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
47.4%
9/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Investigations
Alkaline phosphatase increased
|
63.2%
12/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
57.9%
11/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
47.4%
9/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Psychiatric disorders
Agitation
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Investigations
Alanine aminotransferase increased
|
78.9%
15/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Psychiatric disorders
Anxiety
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.3%
5/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Gastrointestinal disorders
Ascites
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
73.7%
14/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.5%
2/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Gastrointestinal disorders
Bloating
|
10.5%
2/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Investigations
Blood bicarbonate decreased
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Investigations
Blood bilirubin increased
|
26.3%
5/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Eye disorders
Blurred vision
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
15.8%
3/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Injury, poisoning and procedural complications
Bruising
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Gastrointestinal disorders
Cheilitis
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Cardiac disorders
Chest pain - cardiac
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
General disorders
Chills
|
15.8%
3/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Nervous system disorders
Cognitive disturbance
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Gastrointestinal disorders
Colitis
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Psychiatric disorders
Confusion
|
15.8%
3/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Gastrointestinal disorders
Confusion
|
15.8%
3/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.8%
3/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Investigations
Creatinine increased
|
15.8%
3/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
36.8%
7/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
89.5%
17/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Nervous system disorders
Dizziness
|
10.5%
2/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
10.5%
2/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Gastrointestinal disorders
Dry skin
|
21.1%
4/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Nervous system disorders
Dysgeusia
|
36.8%
7/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.5%
2/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.3%
5/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Renal and urinary disorders
Dysuria
|
10.5%
2/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
10.5%
2/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
General disorders
Edema limbs
|
36.8%
7/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
15.8%
3/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
General disorders
Fatigue
|
78.9%
15/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Gastrointestinal disorders
Fecal incontinence
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
General disorders
Fever
|
10.5%
2/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Gastrointestinal disorders
Flatulence
|
21.1%
4/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Vascular disorders
Flushing
|
15.8%
3/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
21.1%
4/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Gastrointestinal disorders
Gastroparesis
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.5%
2/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Infections and infestations
Gum infection
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Skin and subcutaneous tissue disorders
Hair color changes
|
10.5%
2/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Nervous system disorders
Headache
|
36.8%
7/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Vascular disorders
Hematoma
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Vascular disorders
Hot flashes
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Vascular disorders
Hypertension
|
42.1%
8/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
42.1%
8/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
47.4%
9/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
21.1%
4/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
31.6%
6/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
68.4%
13/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Endocrine disorders
Hypothyroidism
|
15.8%
3/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Infections and infestations
Infections and infestations - Other
|
10.5%
2/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Psychiatric disorders
Insomnia
|
21.1%
4/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Nervous system disorders
Lethargy
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Infections and infestations
Lung infection
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Investigations
Lymphocyte count decreased
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Nervous system disorders
Memory impairment
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
15.8%
3/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
10.5%
2/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Gastrointestinal disorders
Nausea
|
47.4%
9/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Investigations
Neutrophil count decreased
|
42.1%
8/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
General disorders
Non-cardiac chest pain
|
10.5%
2/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Gastrointestinal disorders
Oral pain
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
General disorders
Pain
|
26.3%
5/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
10.5%
2/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Cardiac disorders
Palpitations
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Nervous system disorders
Paresthesia
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Infections and infestations
Paronychia
|
10.5%
2/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Investigations
Platelet count decreased
|
84.2%
16/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Renal and urinary disorders
Proteinuria
|
10.5%
2/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.8%
3/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.8%
3/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Gastrointestinal disorders
Rectal pain
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Psychiatric disorders
Restlessness
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Investigations
Serum amylase increased
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
10.5%
2/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Nervous system disorders
Syncope
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Vascular disorders
Thromboembolic event
|
10.5%
2/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Investigations
Thyroid stimulating hormone increased
|
21.1%
4/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Infections and infestations
Tooth infection
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Renal and urinary disorders
Urine discoloration
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
31.6%
6/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Investigations
Weight loss
|
36.8%
7/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Investigations
White blood cell decreased
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
|
Infections and infestations
Wound infection
|
5.3%
1/19 • Adverse events were recorded between the first patient treated (March 2020) and 100 days out from the last patient ending treatment (December 2023). Participants were assessed for AEs for a median of 8.8 months (range 4.7 - 33.7 months)
Adverse events were reviewed and reported after the initial dose of study treatment, during treatment, or within 100 days of the last dose of treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place