Trial Outcomes & Findings for Nintedanib in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors (NCT NCT02399215)
NCT ID: NCT02399215
Last Updated: 2023-12-26
Results Overview
Will be reported using standard Kaplan-Meier methods. Ninety percent confidence intervals for the median PFS will be calculated using Greenwood's formula. Additionally, a confidence interval for the 16-week PFS rate will be obtained using Jeffrey's prior method. The association between survival and quantified variables will be investigated using the Cox-proportional hazard model.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Time interval from initiation of therapy, to its cessation for documentation of PD or death, assessed up to 2 years
Results posted on
2023-12-26
Participant Flow
Participant milestones
| Measure |
Treatment (Nintedanib)
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nintedanib: Given PO
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Nintedanib)
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nintedanib: Given PO
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Overall Study
bowel obstruction (unrelated to dis-ease)
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Nintedanib in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors
Baseline characteristics by cohort
| Measure |
Treatment (Nintedanib)
n=32 Participants
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nintedanib: Given PO
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 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
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 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
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time interval from initiation of therapy, to its cessation for documentation of PD or death, assessed up to 2 yearsWill be reported using standard Kaplan-Meier methods. Ninety percent confidence intervals for the median PFS will be calculated using Greenwood's formula. Additionally, a confidence interval for the 16-week PFS rate will be obtained using Jeffrey's prior method. The association between survival and quantified variables will be investigated using the Cox-proportional hazard model.
Outcome measures
| Measure |
Treatment (Nintedanib)
n=30 Participants
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nintedanib: Given PO
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
PFS
|
11 months
Interval 5.5 to 19.3
|
SECONDARY outcome
Timeframe: Baseline to 30 days post-treatmentPopulation: Patients completed at least 2 EORTC QLQ-GI.NET21 questionnaires are included for this outcome estimate
Quality of life will be investigated calculated by Subjects filing out EORTC Gastrointestinal Neuroendocrine Tumour 21 Questionnaire (QLQ-GI.NET21) A 21 question questionnaire that use a 4-point scale (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). The scores for different scales (i.e. endocrine, gastrointestinal, treatment, social function, disease Related, and global) are calculated by summing related questions from the questionnaire. The range of the subscale scores are from 0 to 100, with higher scores being worse. After the subscale scores being calculated, the Change in quality of life is calculated by subtracting baseline score from end of treatment
Outcome measures
| Measure |
Treatment (Nintedanib)
n=31 Participants
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nintedanib: Given PO
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Change in Quality of Life Score
Change in endocrine scale
|
0 score on a scale
Interval -44.0 to 33.0
|
|
Change in Quality of Life Score
Change in gastrointestinal scale
|
0 score on a scale
Interval -3.0 to 5.0
|
|
Change in Quality of Life Score
Change in treatment scale
|
0 score on a scale
Interval -50.0 to 44.0
|
|
Change in Quality of Life Score
Change in social function scale
|
0 score on a scale
Interval -44.0 to 33.0
|
|
Change in Quality of Life Score
Change in Disease Related Worry Scale
|
-6 score on a scale
Interval -67.0 to 56.0
|
|
Change in Quality of Life Score
Change in Global scale
|
1 score on a scale
Interval -21.0 to 31.0
|
SECONDARY outcome
Timeframe: Baseline to week 8Sample collection will be obtained at baseline and week 8
Outcome measures
| Measure |
Treatment (Nintedanib)
n=32 Participants
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nintedanib: Given PO
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Plasma Concentrations at Steady State (Cpre,ss) of Nintedanib at Baseline and Week 8
|
11.2 ng/mL
Interval 0.9 to 171.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsExact 90% confidence interval estimates using the Clopper-Pearson method will be given for the response rates. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI, response rates are categorized as Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment (Nintedanib)
n=28 Participants
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nintedanib: Given PO
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Clinical Response (Complete Response + Partial Response) Measured Using Standard RECISTv1.1 Criteria
SD
|
26 Participants
|
|
Clinical Response (Complete Response + Partial Response) Measured Using Standard RECISTv1.1 Criteria
PD
|
1 Participants
|
|
Clinical Response (Complete Response + Partial Response) Measured Using Standard RECISTv1.1 Criteria
PR
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 3 years (telephone contact is acceptable).Will be reported using standard Kaplan-Meier methods. Ninety-five percent confidence intervals for the median OS will be calculated using Greenwood's formula. The association between survival and quantified variables will be investigated using the Cox-proportional hazard model.
Outcome measures
| Measure |
Treatment (Nintedanib)
n=32 Participants
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nintedanib: Given PO
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Median OS
|
32.7 months
Interval 27.6 to
90% Upper Confidence Interval was not reached (Not Available), because not enough people deceased to estimate the upper confidence
|
SECONDARY outcome
Timeframe: BaselinePopulation: The FGFR IIIb/IIIcm, Ki-67m and microvessel density scores were not measured (i.e. data not obtained) and analyses were not performed.
Scores will be obtained to investigate association with PFS, clinical response, QOL and survival.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: The appropriate biomarkers were not measured (i.e. data not obtained) and analyses were not performed.
Will be analyzed for all patients and reported in groups based on response.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 8 weeksPopulation: The appropriate cytokine expressions were not measured (i.e. data not obtained) and analyses were not performed.
Will be analyzed for all patients and reported in groups based on response. Changes in pre- and post-treatment cytokine expression will be analyzed using permutation paired t-tests.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 30 days post-treatmentPopulation: The appropriate growth factors were not measured (i.e. data not obtained) and analyses were not performed.
Will be analyzed for all patients and reported in groups based on response. Changes in pre- and post-treatment growth factors will be analyzed using permutation paired t-tests.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Gene mutations and copy number alterations were not measured (i.e. data not obtained) and analyses were not performed.
Gene mutations and copy number alterations in the several pathways particularly mTOR pathway will be evaluated. Will be analyzed for all patients and correlated with clinical outcomes.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Treg levels were not measured and analyses were not performed.
Will be analyzed for all patients and reported in groups based on response.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Nintedanib)
Serious events: 14 serious events
Other events: 31 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Treatment (Nintedanib)
n=32 participants at risk
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nintedanib: Given PO
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Cardiac disorders
Acute myocardial infarction
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Cardiac disorders
Atrial fibrillation
|
6.2%
2/32 • Number of events 3 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Cardiac disorders
Myocardial infarction
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Cardiac disorders
Palpitations
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Eye disorders
Vision blurred
|
3.1%
1/32 • Number of events 3 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Ascites
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Dysphagia
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
6.2%
2/32 • Number of events 2 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Pancreatitis
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
General disorders
Early satiety
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
General disorders
Influenza like illness
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
General disorders
Therapeutic response decreased
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Hepatobiliary disorders
Cholangitis
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Infections and infestations
Cellulitis
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Infections and infestations
Lung infection
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Injury, poisoning and procedural complications
Fall
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Injury, poisoning and procedural complications
Seroma
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
Lymphocyte count decreased
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
Weight decreased
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.1%
1/32 • Number of events 3 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.1%
1/32 • Number of events 2 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.1%
1/32 • Number of events 2 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
1/32 • Number of events 2 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Nervous system disorders
Dizziness
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Nervous system disorders
Dysarthria
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Nervous system disorders
Dysgeusia
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Nervous system disorders
Headache
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Nervous system disorders
Syncope
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Psychiatric disorders
Agitation
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Renal and urinary disorders
Hydronephrosis
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Renal and urinary disorders
Proteinuria
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.4%
3/32 • Number of events 3 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Vascular disorders
Hypertension
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
Other adverse events
| Measure |
Treatment (Nintedanib)
n=32 participants at risk
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nintedanib: Given PO
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
28.1%
9/32 • Number of events 13 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
9.4%
3/32 • Number of events 4 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Cardiac disorders
Angina pectoris
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Cardiac disorders
Aortic valve disease
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Cardiac disorders
Cardiac failure
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Cardiac disorders
Coronary artery disease
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Cardiac disorders
Sinus bradycardia
|
12.5%
4/32 • Number of events 4 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Cardiac disorders
Sinus tachycardia
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Cardiac disorders
Tachycardia
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Cardiac disorders
Tricuspid valve disease
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Endocrine disorders
Adrenal insufficiency
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Endocrine disorders
Hypothyroidism
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Eye disorders
Dry eye
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Eye disorders
Eye disorder
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Eye disorders
Photopsia
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
2/32 • Number of events 3 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
31.2%
10/32 • Number of events 20 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Angular cheilitis
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Ascites
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
2/32 • Number of events 2 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Dental caries
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
37.5%
12/32 • Number of events 19 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Dry mouth
|
9.4%
3/32 • Number of events 3 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Dysphagia
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Faeces pale
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
2/32 • Number of events 2 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Nausea
|
59.4%
19/32 • Number of events 28 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Stomatitis
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Tooth discolouration
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Gastrointestinal disorders
Vomiting
|
37.5%
12/32 • Number of events 17 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
General disorders
Chills
|
6.2%
2/32 • Number of events 2 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
General disorders
Fatigue
|
37.5%
12/32 • Number of events 20 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
General disorders
Influenza like illness
|
15.6%
5/32 • Number of events 5 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
General disorders
Infusion site extravasation
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
General disorders
Localised oedema
|
6.2%
2/32 • Number of events 2 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
General disorders
Non-cardiac chest pain
|
3.1%
1/32 • Number of events 3 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
General disorders
Oedema peripheral
|
12.5%
4/32 • Number of events 5 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
General disorders
Peripheral swelling
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
General disorders
Pyrexia
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Hepatobiliary disorders
Hepatic failure
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Immune system disorders
Contrast media allergy
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Infections and infestations
Cellulitis
|
6.2%
2/32 • Number of events 3 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Infections and infestations
Gastroenteritis
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Infections and infestations
Hepatic infection
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Infections and infestations
Hordeolum
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Infections and infestations
Infection
|
3.1%
1/32 • Number of events 2 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Infections and infestations
Peritonitis
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Infections and infestations
Sinusitis
|
3.1%
1/32 • Number of events 2 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Infections and infestations
Stoma site infection
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Infections and infestations
Tooth infection
|
3.1%
1/32 • Number of events 2 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Infections and infestations
Urinary tract infection
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Injury, poisoning and procedural complications
Contusion
|
21.9%
7/32 • Number of events 7 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
2/32 • Number of events 2 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Injury, poisoning and procedural complications
Injury
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
3.1%
1/32 • Number of events 4 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Injury, poisoning and procedural complications
Stoma site pain
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
Activated partial thromboplastin time
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
Alanine aminotransferase increased
|
28.1%
9/32 • Number of events 16 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
Aspartate aminotransferase increased
|
34.4%
11/32 • Number of events 27 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
Bacterial test positive
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
Blood alkaline phosphatase
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
34.4%
11/32 • Number of events 19 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
Blood bilirubin increased
|
15.6%
5/32 • Number of events 11 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
Blood creatine increased
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
Blood creatinine increased
|
9.4%
3/32 • Number of events 4 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
Blood glucose increased
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
Brain natriuretic peptide
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
Haemoglobin increased
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
Hepatic enzyme increased
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
International normalised ratio increased
|
6.2%
2/32 • Number of events 4 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
Lymphocyte count decreased
|
50.0%
16/32 • Number of events 57 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
Neutrophil count decreased
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
Platelet count decreased
|
37.5%
12/32 • Number of events 16 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
Troponin I increased
|
9.4%
3/32 • Number of events 3 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
Weight decreased
|
40.6%
13/32 • Number of events 19 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
Weight increased
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
White blood cell count decreased
|
28.1%
9/32 • Number of events 21 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Investigations
White blood cell count increased
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
8/32 • Number of events 10 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
50.0%
16/32 • Number of events 46 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
9.4%
3/32 • Number of events 8 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
18.8%
6/32 • Number of events 18 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.4%
3/32 • Number of events 3 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.2%
2/32 • Number of events 4 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.6%
5/32 • Number of events 9 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.5%
4/32 • Number of events 7 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.4%
3/32 • Number of events 3 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
4/32 • Number of events 6 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.2%
2/32 • Number of events 3 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
9.4%
3/32 • Number of events 4 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
2/32 • Number of events 2 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Nervous system disorders
Amnesia
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Nervous system disorders
Dizziness
|
12.5%
4/32 • Number of events 6 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Nervous system disorders
Dysgeusia
|
18.8%
6/32 • Number of events 8 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Nervous system disorders
Headache
|
18.8%
6/32 • Number of events 7 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Nervous system disorders
Memory impairment
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Nervous system disorders
Paraesthesia
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Nervous system disorders
Presyncope
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Nervous system disorders
Syncope
|
6.2%
2/32 • Number of events 2 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Psychiatric disorders
Anxiety
|
6.2%
2/32 • Number of events 2 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Psychiatric disorders
Confusional state
|
3.1%
1/32 • Number of events 4 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Psychiatric disorders
Depression
|
6.2%
2/32 • Number of events 2 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Psychiatric disorders
Insomnia
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Psychiatric disorders
Stress
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
9.4%
3/32 • Number of events 5 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Renal and urinary disorders
Chronic kidney disease
|
6.2%
2/32 • Number of events 2 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Renal and urinary disorders
Dysuria
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Renal and urinary disorders
Proteinuria
|
6.2%
2/32 • Number of events 2 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Reproductive system and breast disorders
Nipple pain
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
3/32 • Number of events 3 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.2%
2/32 • Number of events 2 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.8%
6/32 • Number of events 8 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
2/32 • Number of events 3 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
6.2%
2/32 • Number of events 2 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
6.2%
2/32 • Number of events 3 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
2/32 • Number of events 2 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
3.1%
1/32 • Number of events 2 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
6.2%
2/32 • Number of events 2 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.2%
2/32 • Number of events 3 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Social circumstances
Edentulous
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Surgical and medical procedures
Tooth extraction
|
3.1%
1/32 • Number of events 1 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Vascular disorders
Flushing
|
15.6%
5/32 • Number of events 5 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Vascular disorders
Hypertension
|
53.1%
17/32 • Number of events 38 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
|
Vascular disorders
Hypotension
|
18.8%
6/32 • Number of events 8 • Routine AEs occurring at baseline, Cycle 1-Week 1-Day 1, Cycle 1-Week 3-Day 1, Day 1 of subsequent cycles, End of Treatment, and PFS Follow-Up, will be reported, up to 33 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place