Trial Outcomes & Findings for Testing Whether the Combination of Two Immunotherapy Drugs Have Activity in Recurrent or Persistent Clear Cell Ovarian Cancer (NCT NCT03602586)
NCT ID: NCT03602586
Last Updated: 2024-07-26
Results Overview
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1 criteria. Exact 95% confidence limits, accounting for interim analysis, will be provided in the final report. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=20% decrease in the sum of the longest diameter of target lesions and a 5 mm absolute increase; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Within 7 months of study entry
Results posted on
2024-07-26
Participant Flow
Participant milestones
| Measure |
Treatment (Epacadostat, Pembrolizumab)
Patients receive epacadostat PO BID and pembrolizumab IV over 30 minutes Q3W. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Epacadostat: Given PO (100 mg orally twice a day)
Pembrolizumab: Given IV (200 mg IV infusion over 30 minutes Q3W)
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Treatment (Epacadostat, Pembrolizumab)
Patients receive epacadostat PO BID and pembrolizumab IV over 30 minutes Q3W. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Epacadostat: Given PO (100 mg orally twice a day)
Pembrolizumab: Given IV (200 mg IV infusion over 30 minutes Q3W)
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Testing Whether the Combination of Two Immunotherapy Drugs Have Activity in Recurrent or Persistent Clear Cell Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Epacadostat, Pembrolizumab)
n=14 Participants
Patients receive epacadostat PO BID and pembrolizumab IV over 30 minutes Q3W. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Epacadostat: Given PO
Pembrolizumab: Given IV
|
|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 7 months of study entryPopulation: Evaluable patients
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1 criteria. Exact 95% confidence limits, accounting for interim analysis, will be provided in the final report. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=20% decrease in the sum of the longest diameter of target lesions and a 5 mm absolute increase; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment (Epacadostat, Pembrolizumab)
n=14 Participants
Patients receive epacadostat PO BID and pembrolizumab IV over 30 minutes Q3W. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Epacadostat: Given PO
Pembrolizumab: Given IV
|
|---|---|
|
Complete or Partial Objective Tumor Response
|
3 Participants
|
SECONDARY outcome
Timeframe: Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months.Population: All enrolled patients.
Assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5. Number of participants with an adverse event of grade 3 or higher.
Outcome measures
| Measure |
Treatment (Epacadostat, Pembrolizumab)
n=14 Participants
Patients receive epacadostat PO BID and pembrolizumab IV over 30 minutes Q3W. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Epacadostat: Given PO
Pembrolizumab: Given IV
|
|---|---|
|
Number of Participants With Adverse Events of Grade 3 or Higher
|
9 Participants
|
SECONDARY outcome
Timeframe: Radiographic tumor assessments were completed 12 weeks after the start of treatment, then every 6 weeks for 49 weeks, followed by every 12 weeks until disease progression or treatment discontinuation. The median follow-up time was 4.8 months.Population: Evaluable patients.
Disease progression will be defined using RECIST v. 1.1 criteria. The distributions of PFS will be estimated and graphed using the Kaplan-Meier product limit method. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=20% decrease in the sum of the longest diameter of target lesions and a 5 mm absolute increase; Overall Response (OR) = CR + PR." Progression-free survival (PFS) is defined as the duration of time from the start of study treatment to time of progression or death, whichever occurs first.
Outcome measures
| Measure |
Treatment (Epacadostat, Pembrolizumab)
n=14 Participants
Patients receive epacadostat PO BID and pembrolizumab IV over 30 minutes Q3W. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Epacadostat: Given PO
Pembrolizumab: Given IV
|
|---|---|
|
Progression-free Survival (PFS)
|
14 Participants with progression or death.
|
SECONDARY outcome
Timeframe: Overall survival (OS) is defined as the duration of time from the start of study treatment to time of death or the date of last contact. The median follow-up time for OS was 34.9 months.Population: Evaluable patients.
Assessment of deaths starting from the time of enrollment.
Outcome measures
| Measure |
Treatment (Epacadostat, Pembrolizumab)
n=14 Participants
Patients receive epacadostat PO BID and pembrolizumab IV over 30 minutes Q3W. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Epacadostat: Given PO
Pembrolizumab: Given IV
|
|---|---|
|
Overall Survival (OS)
|
9 Patients who died.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsWill determine whether the ratio of plasma T:K correlates with response to MK-3475 (pembrolizumab) and epacadostat, by evaluating plasma T:K pre-treatment, during treatment, and at disease progression. Pre-treatment levels of T:K ratio in plasma will be assessed for association with radiographic response to MK-3475 (pembrolizumab) and epacadostat. Changes between pre-treatment and post-cycle 1 and changes between post-cycle 1 and disease progression for T:K ratio will be evaluated with paired Student's T tests.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsWill determine whether the presence of PD-L1, IDO-1, Tregs, CD8 TILs, and HLA class I in the tumor microenvironment at baseline correlates with objective response to MK-3475 (pembrolizumab) + epacadostat. Baseline presence of PD-L1, IDO-1, Tregs, TILs, and HLA class I in the tumor microenvironment will also be assessed for correlation with radiographic response to MK-3475 (pembrolizumab) and epacadostat. Will consider logistic regression models for these analyses of continuous biomarkers, if appropriate given the number of responses and if exact tests of response for categorized levels of the biomarkers.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsWill determine whether sPD-L1 levels in plasma are correlated with response to MK-3475 (pembrolizumab) + epacadostat, by evaluating sPD-L1 concentrations pre-treatment, during treatment, and at disease progression. Pre-treatment levels of sPD-L1 in plasma will be assessed for association with radiographic response to MK-3475 (pembrolizumab) and epacadostat. Changes between pre-treatment and post-cycle 1 and changes between post-cycle 1 and disease progression for sPD-L1 will be evaluated with paired Student's T tests.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Epacadostat, Pembrolizumab)
Serious events: 7 serious events
Other events: 14 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Treatment (Epacadostat, Pembrolizumab)
n=14 participants at risk
Patients receive epacadostat PO BID and pembrolizumab IV over 30 minutes Q3W. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Epacadostat: Given PO
Pembrolizumab: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Gastrointestinal disorders
Ileal Obstruction
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
General disorders
Fatigue
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
General disorders
Death Nos
|
14.3%
2/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Investigations
Inr Increased
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Nervous system disorders
Ataxia
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
Other adverse events
| Measure |
Treatment (Epacadostat, Pembrolizumab)
n=14 participants at risk
Patients receive epacadostat PO BID and pembrolizumab IV over 30 minutes Q3W. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Epacadostat: Given PO
Pembrolizumab: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
7/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders - Other
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Cardiac disorders
Sinus Bradycardia
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Endocrine disorders
Hyperthyroidism
|
21.4%
3/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Endocrine disorders
Hypothyroidism
|
28.6%
4/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Eye disorders
Blurred Vision
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Eye disorders
Watering Eyes
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
4/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Gastrointestinal disorders
Dry Mouth
|
21.4%
3/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Gastrointestinal disorders
Constipation
|
57.1%
8/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Gastrointestinal disorders
Colitis
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
7/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Gastrointestinal disorders
Bloating
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
21.4%
3/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Gastrointestinal disorders
Nausea
|
64.3%
9/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Gastrointestinal disorders
Mucositis Oral
|
14.3%
2/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Gastrointestinal disorders
Ascites
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Gastrointestinal disorders
Ileal Obstruction
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Gastrointestinal disorders
Abdominal Pain
|
28.6%
4/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
General disorders
Pain
|
14.3%
2/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
General disorders
Malaise
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
General disorders
Flu Like Symptoms
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
General disorders
Fever
|
21.4%
3/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
General disorders
General Disorders And Administration Site Conditio
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
General disorders
Fatigue
|
78.6%
11/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
General disorders
Edema Limbs
|
21.4%
3/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
General disorders
Death Nos
|
14.3%
2/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
General disorders
Chills
|
14.3%
2/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Immune system disorders
Allergic Reaction
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Infections and infestations
Urinary Tract Infection
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Infections and infestations
Thrush
|
14.3%
2/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Infections and infestations
Vaginal Infection
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Infections and infestations
Skin Infection
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Infections and infestations
Sinusitis
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Infections and infestations
Shingles
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Infections and infestations
Sepsis
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Infections and infestations
Conjunctivitis
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Infections and infestations
Bronchial Infection
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Injury, poisoning and procedural complications
Fall
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Investigations
Thyroid Stimulating Hormone Increased
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Investigations
Platelet Count Decreased
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Investigations
Lymphocyte Count Decreased
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Investigations
Inr Increased
|
14.3%
2/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Investigations
Creatinine Increased
|
21.4%
3/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Investigations
Cholesterol High
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Investigations
Cardiac Troponin I Increased
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Investigations
Blood Bilirubin Increased
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Investigations
White Blood Cell Decreased
|
21.4%
3/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Investigations
Alkaline Phosphatase Increased
|
28.6%
4/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Investigations
Alanine Aminotransferase Increased
|
14.3%
2/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
35.7%
5/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
21.4%
3/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
21.4%
3/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.3%
2/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
21.4%
3/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
14.3%
2/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
35.7%
5/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
7/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
2/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramp
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Hemorrhage
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Nervous system disorders
Seizure
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Nervous system disorders
Nervous System Disorders - Other
|
14.3%
2/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Nervous system disorders
Ischemia Cerebrovascular
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Nervous system disorders
Dysphasia
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Nervous system disorders
Dysgeusia
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Nervous system disorders
Dysarthria
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Nervous system disorders
Dizziness
|
14.3%
2/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Nervous system disorders
Ataxia
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Psychiatric disorders
Insomnia
|
14.3%
2/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Psychiatric disorders
Depression
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Psychiatric disorders
Confusion
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Psychiatric disorders
Anxiety
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Psychiatric disorders
Agitation
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Renal and urinary disorders
Urinary Incontinence
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.4%
3/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
4/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
28.6%
4/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
14.3%
2/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia Syndrome
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Vascular disorders
Hypertension
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Vascular disorders
Hot Flashes
|
14.3%
2/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
|
Vascular disorders
Flushing
|
7.1%
1/14 • Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were assessed from the start of treatment until 30 days after the end of the last treatment cycle. Adverse events were collected for a median time of 5.1 months and a maximum time of 23.8 months. All-Cause mortality was monitored/assessed for a longer time period than Adverse events. All-Cause Mortality monitored/assessed for a median of 34.9 months.
|
Additional Information
Christopher Purdy on behalf of Danielle Enserro, PhD
NRG Oncology
Phone: (716) 845-1300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60