Trial Outcomes & Findings for Pembro/Carbo/Taxol in Endometrial Cancer (NCT NCT02549209)
NCT ID: NCT02549209
Last Updated: 2022-03-02
Results Overview
Objective response rate(ORR) is defined as the percentage of subjects with a partial response or complete response according to immune-related RECIST criteria. Immune-Related Response Criteria: Complete Response(irCR): Disappearance of all lesions in two consecutive observations not less than 4 wk apart. Partial Reponse (irPR): decrease in tumor burden ≥50 %relative to baseline confirmed by a consecutive assessment at least 4 wk after first documentation Stable Disease (irSD): not meeting criteria for irCR or irPR, in absence of irPD
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
From start of treatment Day 1 (D1) and assessed for a maximum of 18 months
Results posted on
2022-03-02
Participant Flow
Participant milestones
| Measure |
Investigational Treatment
Subjects with no prior therapy:
* Pembrolizumab administered at 200 mg
* Paclitaxel administered at 175mg/m2
* Carboplatin administered at an AUC of 6
Subjects with prior external beam radiation therapy (XRT) and/or platinum-based chemotherapy must initiate paclitaxel and carboplatin at a reduced dose:
* Pembrolizumab administered at 200 mg
* Paclitaxel administered at 135mg/m2
* Carboplatin administered at an AUC of 5
Pembrolizumab: Pembrolizumab 200 mg will be administered every 3 weeks for all subjects
Paclitaxel: For subjects with no prior therapy, paclitaxel will be dosed at 175mg/m2 and be administered as a 3-hour continuous IV infusion.
Subjects with prior XRT/platinum-based chemotherapy must initiate paclitaxel at 135mg/m2 and be administered as a 3-hour continuous IV infusion.
Carboplatin: For subjects with no prior therapy, carboplatin will be dosed at an AUC of 6 and given as an IV infusion in 250ml of D5W over 30 minutes.
Subjects with prior XRT/platinum-based chemotherapy must initiate carboplatin at an AUC of 5 given as an IV infusion in 250ml of D5W over 30 minutes.
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembro/Carbo/Taxol in Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Investigational Treatment
n=46 Participants
Subjects with no prior therapy:
* Pembrolizumab administered at 200 mg
* Paclitaxel administered at 175mg/m2
* Carboplatin administered at an AUC of 6
Subjects with prior external beam radiation therapy (XRT) and/or platinum-based chemotherapy must initiate paclitaxel and carboplatin at a reduced dose:
* Pembrolizumab administered at 200 mg
* Paclitaxel administered at 135mg/m2
* Carboplatin administered at an AUC of 5
Pembrolizumab: Pembrolizumab 200 mg will be administered every 3 weeks for all subjects
Paclitaxel: For subjects with no prior therapy, paclitaxel will be dosed at 175mg/m2 and be administered as a 3-hour continuous IV infusion.
Subjects with prior XRT/platinum-based chemotherapy must initiate paclitaxel at 135mg/m2 and be administered as a 3-hour continuous IV infusion.
Carboplatin: For subjects with no prior therapy, carboplatin will be dosed at an AUC of 6 and given as an IV infusion in 250ml of D5W over 30 minutes.
Subjects with prior XRT/platinum-based chemotherapy must initiate carboplatin at an AUC of 5 given as an IV infusion in 250ml of D5W over 30 minutes.
|
|---|---|
|
Age, Continuous
|
66 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=93 Participants
|
|
Stage at Diagnosis
IA
|
13 Participants
n=93 Participants
|
|
Stage at Diagnosis
IB
|
7 Participants
n=93 Participants
|
|
Stage at Diagnosis
II
|
8 Participants
n=93 Participants
|
|
Stage at Diagnosis
IIIA
|
4 Participants
n=93 Participants
|
|
Stage at Diagnosis
IIIC1
|
3 Participants
n=93 Participants
|
|
Stage at Diagnosis
IIIC2
|
3 Participants
n=93 Participants
|
|
Stage at Diagnosis
IVA
|
2 Participants
n=93 Participants
|
|
Stage at Diagnosis
IVB
|
6 Participants
n=93 Participants
|
|
Diagnosis Type
Primary
|
12 Participants
n=93 Participants
|
|
Diagnosis Type
Recurrent
|
34 Participants
n=93 Participants
|
|
Tumor Grade
1
|
14 Participants
n=93 Participants
|
|
Tumor Grade
2
|
10 Participants
n=93 Participants
|
|
Tumor Grade
3
|
22 Participants
n=93 Participants
|
|
Histology
Clear Cell
|
3 Participants
n=93 Participants
|
|
Histology
Endometrioid
|
27 Participants
n=93 Participants
|
|
Histology
Mucinous
|
0 Participants
n=93 Participants
|
|
Histology
Other
|
5 Participants
n=93 Participants
|
|
Histology
Serous
|
11 Participants
n=93 Participants
|
|
Previous Treatment
Carboplatin/paclitaxel
|
19 participants
n=93 Participants
|
|
Previous Treatment
External beam radiotherapy
|
23 participants
n=93 Participants
|
|
Previous Treatment
Brachytherapy
|
14 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From start of treatment Day 1 (D1) and assessed for a maximum of 18 monthsPopulation: Forty-three of the enrolled patients were evaluable for efficacy using the primary endpoint of ORR. Three patients received a single dose of therapy and were not evaluable for response due to transition to hospice care, a severe allergic reaction to therapy, or no further follow up.
Objective response rate(ORR) is defined as the percentage of subjects with a partial response or complete response according to immune-related RECIST criteria. Immune-Related Response Criteria: Complete Response(irCR): Disappearance of all lesions in two consecutive observations not less than 4 wk apart. Partial Reponse (irPR): decrease in tumor burden ≥50 %relative to baseline confirmed by a consecutive assessment at least 4 wk after first documentation Stable Disease (irSD): not meeting criteria for irCR or irPR, in absence of irPD
Outcome measures
| Measure |
Investigational Treatment
n=43 Participants
Subjects with no prior therapy:
* Pembrolizumab administered at 200 mg
* Paclitaxel administered at 175mg/m2
* Carboplatin administered at an AUC of 6
Subjects with prior external beam radiation therapy (XRT) and/or platinum-based chemotherapy must initiate paclitaxel and carboplatin at a reduced dose:
* Pembrolizumab administered at 200 mg
* Paclitaxel administered at 135mg/m2
* Carboplatin administered at an AUC of 5
Pembrolizumab: Pembrolizumab 200 mg will be administered every 3 weeks for all subjects
Paclitaxel: For subjects with no prior therapy, paclitaxel will be dosed at 175mg/m2 and be administered as a 3-hour continuous IV infusion.
Subjects with prior XRT/platinum-based chemotherapy must initiate paclitaxel at 135mg/m2 and be administered as a 3-hour continuous IV infusion.
Carboplatin: For subjects with no prior therapy, carboplatin will be dosed at an AUC of 6 and given as an IV infusion in 250ml of D5W over 30 minutes.
Subjects with prior XRT/platinum-based chemotherapy must initiate carboplatin at an AUC of 5 given as an IV infusion in 250ml of D5W over 30 minutes.
|
|---|---|
|
Objective Response Rates (ORR)
|
74.4 percentage of participants
Interval 58.8 to 86.5
|
SECONDARY outcome
Timeframe: From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )Proportion of subjects who experience ≥ Grade 3 toxicity regardless of relation according per Common Toxicity Criteria for Adverse Effects (CTCAE) v4 criteria while receiving pembrolizumab in combination with standard carboplatin/paclitaxel therapy
Outcome measures
| Measure |
Investigational Treatment
n=46 Participants
Subjects with no prior therapy:
* Pembrolizumab administered at 200 mg
* Paclitaxel administered at 175mg/m2
* Carboplatin administered at an AUC of 6
Subjects with prior external beam radiation therapy (XRT) and/or platinum-based chemotherapy must initiate paclitaxel and carboplatin at a reduced dose:
* Pembrolizumab administered at 200 mg
* Paclitaxel administered at 135mg/m2
* Carboplatin administered at an AUC of 5
Pembrolizumab: Pembrolizumab 200 mg will be administered every 3 weeks for all subjects
Paclitaxel: For subjects with no prior therapy, paclitaxel will be dosed at 175mg/m2 and be administered as a 3-hour continuous IV infusion.
Subjects with prior XRT/platinum-based chemotherapy must initiate paclitaxel at 135mg/m2 and be administered as a 3-hour continuous IV infusion.
Carboplatin: For subjects with no prior therapy, carboplatin will be dosed at an AUC of 6 and given as an IV infusion in 250ml of D5W over 30 minutes.
Subjects with prior XRT/platinum-based chemotherapy must initiate carboplatin at an AUC of 5 given as an IV infusion in 250ml of D5W over 30 minutes.
|
|---|---|
|
Proportion of Subjects Who Experience ≥ Grade 3 Toxicity According Per Common Toxicity Criteria for Adverse Effects (CTCAE) v4 Criteria
|
0.74 proportion of participants
|
Adverse Events
Investigational Treatment
Serious events: 16 serious events
Other events: 46 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Investigational Treatment
n=46 participants at risk
Subjects with no prior therapy:
* Pembrolizumab administered at 200 mg
* Paclitaxel administered at 175mg/m2
* Carboplatin administered at an AUC of 6
Subjects with prior external beam radiation therapy (XRT) and/or platinum-based chemotherapy must initiate paclitaxel and carboplatin at a reduced dose:
* Pembrolizumab administered at 200 mg
* Paclitaxel administered at 135mg/m2
* Carboplatin administered at an AUC of 5
Pembrolizumab: Pembrolizumab 200 mg will be administered every 3 weeks for all subjects
Paclitaxel: For subjects with no prior therapy, paclitaxel will be dosed at 175mg/m2 and be administered as a 3-hour continuous IV infusion.
Subjects with prior XRT/platinum-based chemotherapy must initiate paclitaxel at 135mg/m2 and be administered as a 3-hour continuous IV infusion.
Carboplatin: For subjects with no prior therapy, carboplatin will be dosed at an AUC of 6 and given as an IV infusion in 250ml of D5W over 30 minutes.
Subjects with prior XRT/platinum-based chemotherapy must initiate carboplatin at an AUC of 5 given as an IV infusion in 250ml of D5W over 30 minutes.
|
|---|---|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Immune system disorders
ANAPHYLAXIS
|
2.2%
1/46 • Number of events 3 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Blood and lymphatic system disorders
ANEMIA
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Nervous system disorders
ATAXIA
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Gastrointestinal disorders
COLITIS
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
4.3%
2/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
2.2%
1/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
General disorders
FATIGUE
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
General disorders
FEVER
|
6.5%
3/46 • Number of events 3 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Vascular disorders
HEMATOMA
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
4.3%
2/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Infections and infestations
INFECTIONS AND INFESTATIONS
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS LOWER LIMB
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Gastrointestinal disorders
NAUSEA
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Nervous system disorders
SYNCOPE
|
4.3%
2/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Ear and labyrinth disorders
VESTIBULAR DISORDER
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Gastrointestinal disorders
VOMITING
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
Other adverse events
| Measure |
Investigational Treatment
n=46 participants at risk
Subjects with no prior therapy:
* Pembrolizumab administered at 200 mg
* Paclitaxel administered at 175mg/m2
* Carboplatin administered at an AUC of 6
Subjects with prior external beam radiation therapy (XRT) and/or platinum-based chemotherapy must initiate paclitaxel and carboplatin at a reduced dose:
* Pembrolizumab administered at 200 mg
* Paclitaxel administered at 135mg/m2
* Carboplatin administered at an AUC of 5
Pembrolizumab: Pembrolizumab 200 mg will be administered every 3 weeks for all subjects
Paclitaxel: For subjects with no prior therapy, paclitaxel will be dosed at 175mg/m2 and be administered as a 3-hour continuous IV infusion.
Subjects with prior XRT/platinum-based chemotherapy must initiate paclitaxel at 135mg/m2 and be administered as a 3-hour continuous IV infusion.
Carboplatin: For subjects with no prior therapy, carboplatin will be dosed at an AUC of 6 and given as an IV infusion in 250ml of D5W over 30 minutes.
Subjects with prior XRT/platinum-based chemotherapy must initiate carboplatin at an AUC of 5 given as an IV infusion in 250ml of D5W over 30 minutes.
|
|---|---|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
2.2%
1/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
32.6%
15/46 • Number of events 15 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
|
19.6%
9/46 • Number of events 13 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
4.3%
2/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Psychiatric disorders
AGITATION
|
6.5%
3/46 • Number of events 4 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
15.2%
7/46 • Number of events 8 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
17.4%
8/46 • Number of events 12 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS
|
6.5%
3/46 • Number of events 3 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
45.7%
21/46 • Number of events 26 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Blood and lymphatic system disorders
ANEMIA
|
78.3%
36/46 • Number of events 92 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
26.1%
12/46 • Number of events 19 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Psychiatric disorders
ANXIETY
|
21.7%
10/46 • Number of events 11 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
23.9%
11/46 • Number of events 14 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
10.9%
5/46 • Number of events 5 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Gastrointestinal disorders
ASCITES
|
2.2%
1/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
21.7%
10/46 • Number of events 11 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
23.9%
11/46 • Number of events 11 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Renal and urinary disorders
BLADDER SPASM
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Gastrointestinal disorders
BLOATING
|
4.3%
2/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Blood and lymphatic system disorders
BLOOD AND LYMPHATIC SYSTEM DISORDERS
|
10.9%
5/46 • Number of events 6 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
6.5%
3/46 • Number of events 5 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Eye disorders
BLURRED VISION
|
8.7%
4/46 • Number of events 4 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Infections and infestations
BRONCHIAL INFECTION
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Injury, poisoning and procedural complications
BRUISING
|
10.9%
5/46 • Number of events 6 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Cardiac disorders
CARDIAC DISORDERS
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Eye disorders
CATARACT
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Musculoskeletal and connective tissue disorders
CHEST WALL PAIN
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
General disorders
CHILLS
|
6.5%
3/46 • Number of events 4 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Investigations
CHOLESTEROL HIGH
|
10.9%
5/46 • Number of events 5 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Renal and urinary disorders
CHRONIC KIDNEY DISEASE
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Gastrointestinal disorders
COLITIS
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Gastrointestinal disorders
COLONIC FISTULA
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Psychiatric disorders
CONFUSION
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Congenital, familial and genetic disorders
CONGENITAL, FAMILIAL AND GENETIC DISORDERS
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Gastrointestinal disorders
CONSTIPATION
|
37.0%
17/46 • Number of events 28 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
41.3%
19/46 • Number of events 21 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Investigations
CREATININE INCREASED
|
10.9%
5/46 • Number of events 6 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Renal and urinary disorders
CYSTITIS NONINFECTIVE
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
8.7%
4/46 • Number of events 6 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Psychiatric disorders
DEPRESSION
|
15.2%
7/46 • Number of events 8 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Gastrointestinal disorders
DIARRHEA
|
47.8%
22/46 • Number of events 32 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Nervous system disorders
DIZZINESS
|
17.4%
8/46 • Number of events 12 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Gastrointestinal disorders
DRY MOUTH
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
8.7%
4/46 • Number of events 4 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Nervous system disorders
DYSGEUSIA
|
13.0%
6/46 • Number of events 8 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
4.3%
2/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
37.0%
17/46 • Number of events 25 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Ear and labyrinth disorders
EAR PAIN
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
General disorders
EDEMA LIMBS
|
32.6%
15/46 • Number of events 17 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
General disorders
EDEMA TRUNK
|
4.3%
2/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Investigations
ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Endocrine disorders
ENDOCRINE DISORDERS
|
13.0%
6/46 • Number of events 7 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Gastrointestinal disorders
ESOPHAGITIS
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Eye disorders
EYE DISORDERS
|
6.5%
3/46 • Number of events 3 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Injury, poisoning and procedural complications
FALL
|
15.2%
7/46 • Number of events 8 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
General disorders
FATIGUE
|
58.7%
27/46 • Number of events 42 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Gastrointestinal disorders
FECAL INCONTINENCE
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
General disorders
FEVER
|
8.7%
4/46 • Number of events 4 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
4.3%
2/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Vascular disorders
FLUSHING
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Injury, poisoning and procedural complications
FRACTURE
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
General disorders
GAIT DISTURBANCE
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
8.7%
4/46 • Number of events 4 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS
|
10.9%
5/46 • Number of events 5 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
General disorders
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
|
17.4%
8/46 • Number of events 17 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Psychiatric disorders
HALLUCINATIONS
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Nervous system disorders
HEADACHE
|
13.0%
6/46 • Number of events 6 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Renal and urinary disorders
HEMATURIA
|
23.9%
11/46 • Number of events 15 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
4.3%
2/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
41.3%
19/46 • Number of events 46 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Vascular disorders
HYPERTENSION
|
50.0%
23/46 • Number of events 44 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
10.9%
5/46 • Number of events 5 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDEMIA
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Metabolism and nutrition disorders
HYPERURICEMIA
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
21.7%
10/46 • Number of events 15 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
8.7%
4/46 • Number of events 6 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
30.4%
14/46 • Number of events 29 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
41.3%
19/46 • Number of events 33 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
10.9%
5/46 • Number of events 10 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
23.9%
11/46 • Number of events 17 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Vascular disorders
HYPOTENSION
|
13.0%
6/46 • Number of events 8 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
37.0%
17/46 • Number of events 20 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Immune system disorders
IMMUNE SYSTEM DISORDERS
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Infections and infestations
INFECTIONS AND INFESTATIONS
|
10.9%
5/46 • Number of events 5 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
General disorders
INFUSION RELATED REACTION
|
10.9%
5/46 • Number of events 7 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
General disorders
INFUSION SITE EXTRAVASATION
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Injury, poisoning and procedural complications
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Investigations
INR INCREASED
|
6.5%
3/46 • Number of events 3 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Psychiatric disorders
INSOMNIA
|
17.4%
8/46 • Number of events 9 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Investigations
INVESTIGATIONS
|
17.4%
8/46 • Number of events 9 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Nervous system disorders
LETHARGY
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Infections and infestations
LIP INFECTION
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Infections and infestations
LUNG INFECTION
|
2.2%
1/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Vascular disorders
LYMPHEDEMA
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
52.2%
24/46 • Number of events 79 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
8.7%
4/46 • Number of events 5 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Metabolism and nutrition disorders
METABOLISM AND NUTRITION DISORDERS
|
6.5%
3/46 • Number of events 3 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
6.5%
3/46 • Number of events 5 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS LOWER LIMB
|
4.3%
2/46 • Number of events 3 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER
|
13.0%
6/46 • Number of events 9 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
19.6%
9/46 • Number of events 11 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Musculoskeletal and connective tissue disorders
MYOSITIS
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
6.5%
3/46 • Number of events 3 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Gastrointestinal disorders
NAUSEA
|
52.2%
24/46 • Number of events 43 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
6.5%
3/46 • Number of events 3 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
|
4.3%
2/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Nervous system disorders
NERVOUS SYSTEM DISORDERS
|
4.3%
2/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
37.0%
17/46 • Number of events 33 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
4.3%
2/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Metabolism and nutrition disorders
OBESITY
|
6.5%
3/46 • Number of events 4 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
4.3%
2/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
General disorders
PAIN
|
6.5%
3/46 • Number of events 3 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
17.4%
8/46 • Number of events 9 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
|
4.3%
2/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Nervous system disorders
PARESTHESIA
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
8.7%
4/46 • Number of events 5 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
56.5%
26/46 • Number of events 44 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Infections and infestations
PHARYNGITIS
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Investigations
PLATELET COUNT DECREASED
|
45.7%
21/46 • Number of events 58 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Nervous system disorders
PRESYNCOPE
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
10.9%
5/46 • Number of events 7 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Renal and urinary disorders
PROTEINURIA
|
15.2%
7/46 • Number of events 10 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
13.0%
6/46 • Number of events 7 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Skin and subcutaneous tissue disorders
RASH ACNEIFORM
|
8.7%
4/46 • Number of events 6 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
23.9%
11/46 • Number of events 15 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Gastrointestinal disorders
RECTAL HEMORRHAGE
|
6.5%
3/46 • Number of events 3 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Gastrointestinal disorders
RECTAL MUCOSITIS
|
2.2%
1/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Renal and urinary disorders
RENAL AND URINARY DISORDERS
|
15.2%
7/46 • Number of events 12 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Reproductive system and breast disorders
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
|
4.3%
2/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
|
8.7%
4/46 • Number of events 5 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Eye disorders
RETINAL VASCULAR DISORDER
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Infections and infestations
SEPSIS
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
15.2%
7/46 • Number of events 11 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Infections and infestations
SINUSITIS
|
4.3%
2/46 • Number of events 3 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
|
10.9%
5/46 • Number of events 7 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Infections and infestations
SKIN INFECTION
|
2.2%
1/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Gastrointestinal disorders
STOMACH PAIN
|
4.3%
2/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Nervous system disorders
SYNCOPE
|
4.3%
2/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
10.9%
5/46 • Number of events 5 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Ear and labyrinth disorders
TINNITUS
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
6.5%
3/46 • Number of events 3 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
6.5%
3/46 • Number of events 4 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
6.5%
3/46 • Number of events 3 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Renal and urinary disorders
URINARY RETENTION
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
21.7%
10/46 • Number of events 13 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Renal and urinary disorders
URINARY TRACT PAIN
|
13.0%
6/46 • Number of events 6 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Renal and urinary disorders
URINARY URGENCY
|
2.2%
1/46 • Number of events 3 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Reproductive system and breast disorders
UTERINE HEMORRHAGE
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Reproductive system and breast disorders
VAGINAL DISCHARGE
|
2.2%
1/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Reproductive system and breast disorders
VAGINAL DRYNESS
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Reproductive system and breast disorders
VAGINAL HEMORRHAGE
|
4.3%
2/46 • Number of events 5 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Ear and labyrinth disorders
VERTIGO
|
2.2%
1/46 • Number of events 3 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Gastrointestinal disorders
VOMITING
|
19.6%
9/46 • Number of events 11 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Eye disorders
WATERING EYES
|
4.3%
2/46 • Number of events 2 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Investigations
WEIGHT GAIN
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Investigations
WEIGHT LOSS
|
30.4%
14/46 • Number of events 23 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
2.2%
1/46 • Number of events 1 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
47.8%
22/46 • Number of events 63 • From time of consent to up to a maximum of 7 months(30 days following cessation of treatment )
CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place