Trial Outcomes & Findings for Pemetrexed and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer (NCT NCT00691301)
NCT ID: NCT00691301
Last Updated: 2018-01-09
Results Overview
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression or study withdrawal; and at any other time if clinically indicated, up to 5 years.
Results posted on
2018-01-09
Participant Flow
Participant milestones
| Measure |
Pemetrexed and Cisplatin
Pemtrexed plus cisplatin on day 1 every 21 days
cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of
pemetrexed disodium
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
54
|
Reasons for withdrawal
| Measure |
Pemetrexed and Cisplatin
Pemtrexed plus cisplatin on day 1 every 21 days
cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of
pemetrexed disodium
|
|---|---|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
Death
|
2
|
|
Overall Study
Lack of Efficacy
|
32
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Concurrent illness
|
2
|
|
Overall Study
other reason
|
3
|
|
Overall Study
Did not initiate study treatment
|
1
|
Baseline Characteristics
Pemetrexed and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
Baseline characteristics by cohort
| Measure |
Pemetrexed and Cisplatin
n=54 Participants
Pemtrexed plus cisplatin on day 1 every 21 days
cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of
pemetrexed disodium
|
|---|---|
|
Age, Customized
20-29 years
|
3 participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
10 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
23 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
15 participants
n=5 Participants
|
|
Age, Customized
>60 years
|
3 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 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
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression or study withdrawal; and at any other time if clinically indicated, up to 5 years.Population: Individuals who initiated study treatment
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Outcome measures
| Measure |
Pemetrexed and Cisplatin
n=54 Participants
Pemtrexed plus cisplatin on day 1 every 21 days
cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of
pemetrexed disodium
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
Complete Response
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
|
Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
Partial Response
|
16 participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: every 21 days during study treatment and up to 30 days after the last cycle of treatment.Population: All eligible and evaluable patients.
All eligible and evaluable patients
Outcome measures
| Measure |
Pemetrexed and Cisplatin
n=54 Participants
Pemtrexed plus cisplatin on day 1 every 21 days
cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of
pemetrexed disodium
|
Grade 1 (CTCAE v 3.0)
n=54 Participants
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
n=54 Participants
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
n=54 Participants
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
n=54 Participants
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
n=54 Participants
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Frequency and Severity of Observed Adverse Effects
Leukopenia
|
16 Participants
|
8 Participants
|
15 Participants
|
12 Participants
|
3 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Pain
|
18 Participants
|
11 Participants
|
13 Participants
|
12 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Pulmonary
|
37 Participants
|
9 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Thrombocytopenia
|
32 Participants
|
11 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Neutropenia
|
20 Participants
|
5 Participants
|
10 Participants
|
12 Participants
|
7 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Anemia
|
2 Participants
|
17 Participants
|
22 Participants
|
6 Participants
|
7 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Other hematologic
|
49 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Allergy/immunology
|
49 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Auditory/ear
|
39 Participants
|
0 Participants
|
14 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Cardiac
|
47 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Coagulation
|
53 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Constitutional
|
6 Participants
|
12 Participants
|
23 Participants
|
12 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Dermatologic
|
24 Participants
|
20 Participants
|
9 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Endocrine
|
53 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Nausea
|
7 Participants
|
19 Participants
|
22 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Vomiting
|
19 Participants
|
11 Participants
|
17 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Gastrointestinal
|
4 Participants
|
15 Participants
|
24 Participants
|
10 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Genitourinary/renal
|
43 Participants
|
6 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Hemorrhage
|
44 Participants
|
7 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Infection
|
37 Participants
|
0 Participants
|
11 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Lymphatics
|
42 Participants
|
5 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Metabolic
|
10 Participants
|
19 Participants
|
10 Participants
|
10 Participants
|
5 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Musculoskeletal
|
50 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Neurosensory
|
31 Participants
|
15 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Other neurological
|
42 Participants
|
8 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Ocular/visual
|
44 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Sexual/reproductive
|
53 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Syndromes
|
52 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Effects
Vascular
|
50 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From enrollment onto the study until the onset of disease progression or death, up to 5 yearsPopulation: Individuals who initiated study treatment
Duration of progression-free survival in months.
Outcome measures
| Measure |
Pemetrexed and Cisplatin
n=54 Participants
Pemtrexed plus cisplatin on day 1 every 21 days
cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of
pemetrexed disodium
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Progression-free Survival
|
5.6 months
Interval 2.6 to 9.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually, up to 5 years.Population: Eligible and treated patients
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Outcome measures
| Measure |
Pemetrexed and Cisplatin
n=54 Participants
Pemtrexed plus cisplatin on day 1 every 21 days
cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of
pemetrexed disodium
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Duration of Overall Survival
|
12.3 months
Interval 0.3 to 38.6
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Pemetrexed and Cisplatin
Serious events: 23 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed and Cisplatin
n=54 participants at risk
Pemtrexed plus cisplatin on day 1 every 21 days
cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of
pemetrexed disodium
|
|---|---|
|
Immune system disorders
Allergic Reaction/Hypersensitivity
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Blood and lymphatic system disorders
Leukocytes
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Cardiac disorders
Hypertension
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Death No Ctcae Term - Sudden Death
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Fistula, Gi - Colon/Cecum/Appendix
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Perforation, Gi - Appendix
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Perforation, Gi - Colon
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Dehydration
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Nausea
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Diarrhea
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
5.6%
3/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Hemorrhage, Gi - Stomach
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Skin (Cellulitis)
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Febrile Neutropenia
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Inf Unknown Anc: Skin (Cellulitis)
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Chest Wall
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Head/Headache
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Back
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Abdominal Pain Nos
|
5.6%
3/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Stricture, Anastomotic, Gu - Ureter
|
5.6%
3/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
Other adverse events
| Measure |
Pemetrexed and Cisplatin
n=54 participants at risk
Pemtrexed plus cisplatin on day 1 every 21 days
cisplatin: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of
pemetrexed disodium
|
|---|---|
|
Immune system disorders
Allergy/Immunology - Other
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Immune system disorders
Allergic Reaction/Hypersensitivity
|
5.6%
3/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Immune system disorders
Rhinitis
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Ear and labyrinth disorders
Auditory/Ear - Other
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Ear and labyrinth disorders
Hearing (Without Monitoring Program)
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Ear and labyrinth disorders
Tinnitus
|
25.9%
14/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Ear and labyrinth disorders
Hearing (Monitoring Program)
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Blood and lymphatic system disorders
Neutrophils
|
63.0%
34/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Blood and lymphatic system disorders
Platelets
|
40.7%
22/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
7.4%
4/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Blood and lymphatic system disorders
Leukocytes
|
70.4%
38/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
96.3%
52/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Cardiac disorders
S/N Arrhythmia: Atrial Fibrillation
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Cardiac disorders
Palpitations
|
7.4%
4/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Tachycardia
|
5.6%
3/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Bradycardia
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Cardiac disorders
Hypertension
|
9.3%
5/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Cardiac disorders
Pericardial Effusion
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Inr
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Ptt
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Constitutional Symptoms - Other
|
5.6%
3/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Sweating
|
29.6%
16/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Weight Gain
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Fever
|
29.6%
16/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Weight Loss
|
7.4%
4/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Obesity
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Rigors/Chills
|
20.4%
11/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Fatigue
|
87.0%
47/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Insomnia
|
18.5%
10/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (Scalp Or Body)
|
31.5%
17/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.6%
3/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.4%
11/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
11.1%
6/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Decubitus
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.0%
7/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
7.4%
4/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Endocrine disorders
Hot Flashes
|
7.4%
4/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Flatulence
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Fistula, Gi - Small Bowel Nos
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Heartburn
|
7.4%
4/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Dental: Teeth
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Dysphagia
|
13.0%
7/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Taste Alteration
|
16.7%
9/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Dry Mouth
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Oral Cavity
|
13.0%
7/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Necrosis, Gi - Stoma
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Anus
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Oral Cavity
|
24.1%
13/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Esophagus
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Vomiting
|
64.8%
35/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Anorexia
|
61.1%
33/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Dehydration
|
5.6%
3/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Constipation
|
68.5%
37/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Nausea
|
87.0%
47/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Gastrointestinal disorders
Diarrhea
|
48.1%
26/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Hemorrhage, Gu - Urinary Nos
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
16.7%
9/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Hemorrhage, Gi - Rectum
|
14.8%
8/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Hemorrhage/Pulmonary - Nose
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Hematoma
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Hemorrhage, Gi - Anus
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Hemorrhage, Gu - Uterus
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Hemorrhage, Gi - Oral Cavity
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Hemorrhage, Gu - Kidney
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Hemorrhage, Gi - Stomach
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Hemorrhage, Gi - Abdomen Nos
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Blood
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Salivary Gland
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
24.1%
13/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Infection - Other
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Inf Unknown Anc: Vagina
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc:peritoneal Cavity
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Inf Unknown Anc: Urinary Tract Nos
|
5.6%
3/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Inf Unknown Anc: Salivary Gland
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Blood and lymphatic system disorders
Edema: Trunk/Genital
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Blood and lymphatic system disorders
Edema: Limb
|
27.8%
15/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Blood and lymphatic system disorders
Edema: Head And Neck
|
5.6%
3/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Ast
|
22.2%
12/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
5.6%
3/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Proteinuria
|
5.6%
3/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Creatinine
|
38.9%
21/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.9%
14/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Alt
|
20.4%
11/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
27.8%
15/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Bilirubin
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.6%
3/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
37.0%
20/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Bicarbonate, Serum-Low
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
22.2%
12/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.4%
4/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
59.3%
32/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
37.0%
20/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
25.9%
14/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/St: Other
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.6%
3/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Whole Body/Generalized
|
7.4%
4/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Upper
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Neurology - Other
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Mood Alteration - Depression
|
27.8%
15/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Mood Alteration - Anxiety
|
20.4%
11/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Mood Alteration - Agitation
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Seizure
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Somnolence
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Cognitive Disturbance
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Confusion
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Memory Impairment
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Dizziness
|
13.0%
7/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Neuropathy-Sensory
|
46.3%
25/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Nervous system disorders
Neuropathy-Motor
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Eye disorders
Ocular/Visual - Other
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Eye disorders
Watery Eye
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Eye disorders
Dry Eye
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Eye disorders
Flashing Lights/Floaters
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Eye disorders
Diplopia
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Eye disorders
Blurred Vision
|
16.7%
9/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain - Other
|
20.4%
11/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Urethra
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Pelvis
|
14.8%
8/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Chest /Thorax Nos
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Chest Wall
|
9.3%
5/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Throat/Pharynx/Larynx
|
7.4%
4/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Head/Headache
|
46.3%
25/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Neck
|
7.4%
4/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Extremity-Limb
|
24.1%
13/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Buttock
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Back
|
33.3%
18/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Joint
|
11.1%
6/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Bone
|
5.6%
3/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Lymph Node
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Kidney
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Bladder
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Pain Nos
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Stomach
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Rectum
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Abdominal Pain Nos
|
31.5%
17/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Oral - Gums
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Middle Ear
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: External Ear
|
5.6%
3/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Cardiac/ Heart
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Muscle
|
5.6%
3/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Pain: Anus
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.8%
15/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dlco
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
38.9%
21/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
7.4%
4/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Stricture, Anastomotic, Gu - Ureter
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Cystitis
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Urinary Retention
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Obstruction, Gu - Ureter
|
7.4%
4/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Incontinence, Urinary
|
5.6%
3/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Fistula, Gu - Vagina
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Bladder Spasm
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Renal Failure
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Renal and urinary disorders
Urinary Frequency
|
18.5%
10/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
9.3%
5/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Syndromes - Other
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
General disorders
Cytokine Release Syndrome
|
3.7%
2/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Thrombosis/Embolism (Vascular Access-Related)
|
1.9%
1/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
14.8%
8/54 • All adverse events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
|
Additional Information
Linda Gedeon for Mark Brady, PhD
Gynecologic Oncology Group
Phone: 716-845-1169
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place