Trial Outcomes & Findings for Paclitaxel With or Without Pazopanib Hydrochloride in Treating Patients With Persistent or Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer (NCT NCT01468909)
NCT ID: NCT01468909
Last Updated: 2019-07-23
Results Overview
The time from randomization until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
106 participants
Primary outcome timeframe
For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 21-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, Up to 5 years
Results posted on
2019-07-23
Participant Flow
106 patients were enrolled between December 2011 and April 2013.
Participant milestones
| Measure |
Paclitaxel + Placebo
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Placebo PO daily
|
Paclitaxel + Pazopanib
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Pazopanib 800 mg PO daily
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
54
|
|
Overall Study
COMPLETED
|
50
|
52
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Paclitaxel + Placebo
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Placebo PO daily
|
Paclitaxel + Pazopanib
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Pazopanib 800 mg PO daily
|
|---|---|---|
|
Overall Study
Never Treated
|
2
|
2
|
Baseline Characteristics
Paclitaxel With or Without Pazopanib Hydrochloride in Treating Patients With Persistent or Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer
Baseline characteristics by cohort
| Measure |
Paclitaxel + Placebo
n=52 Participants
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Placebo PO daily
|
Paclitaxel + Pazopanib
n=54 Participants
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Pazopanib 800 mg PO daily
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age · 30-39 years
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Age, Customized
Age · 40-49 years
|
7 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Age, Customized
Age · 50-59 years
|
14 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
31 Participants
n=35 Participants
|
|
Age, Customized
Age · 60-69 years
|
18 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
36 Participants
n=35 Participants
|
|
Age, Customized
Age · 70-79 years
|
10 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Age, Customized
Age · 80 + years
|
1 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=39 Participants
|
54 Participants
n=41 Participants
|
106 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=39 Participants
|
46 Participants
n=41 Participants
|
88 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 21-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, Up to 5 yearsPopulation: All randomized patients
The time from randomization until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Paclitaxel + Placebo
n=52 Participants
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Placebo PO daily
|
Paclitaxel + Pazopanib
n=54 Participants
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Pazopanib 800 mg PO daily
|
|---|---|---|
|
Progression Free Survival
|
6.2 months
Interval 5.5 to 8.5
|
7.5 months
Interval 5.3 to 9.1
|
SECONDARY outcome
Timeframe: From baseline to 30 days after last dose of drug.Population: Treated and eligible patients
All grade 3 or greater Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
Outcome measures
| Measure |
Paclitaxel + Placebo
n=50 Participants
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Placebo PO daily
|
Paclitaxel + Pazopanib
n=52 Participants
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Pazopanib 800 mg PO daily
|
|---|---|---|
|
Adverse Events as Assessed by CTCAE v.4
|
18 participants
Interval 11.0 to 26.0
|
45 participants
Interval 38.0 to 49.0
|
SECONDARY outcome
Timeframe: Every other cycle for 6 months, then every 3 months until disease progression,Up to 5 yearsPopulation: All randomized patients.
Patients with Complete and Partial Tumor Response by RECIST 1.1. Responses (CR and PR) require confirmation at greater than or equal to 4 weeks from initial documentation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Paclitaxel + Placebo
n=52 Participants
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Placebo PO daily
|
Paclitaxel + Pazopanib
n=54 Participants
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Pazopanib 800 mg PO daily
|
|---|---|---|
|
Proportion of Participants With Tumor Response by RECIST
|
0.192 proportion of participants
Interval 0.096 to 0.325
|
0.259 proportion of participants
Interval 0.15 to 0.397
|
SECONDARY outcome
Timeframe: Prior to each cycle of treatment. Then follow-up every three months for 2 years and then every 6 months for 3 years, up to 5 years.Population: CA-125 Evaluable patients
Response as evaluated by CA-125 levels. Response is indicated if CA-125 reduced by 50% of the baseline measure.
Outcome measures
| Measure |
Paclitaxel + Placebo
n=32 Participants
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Placebo PO daily
|
Paclitaxel + Pazopanib
n=39 Participants
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Pazopanib 800 mg PO daily
|
|---|---|---|
|
Percentage of Participants With Tumor Response by CA-125
|
41 percentage of participants
Interval 24.0 to 59.0
|
72 percentage of participants
Interval 55.0 to 85.0
|
SECONDARY outcome
Timeframe: Every cycle while patient is receiving protocol therapy. Patients monitored for survival after off therapy every 3 months for 2 years, then every 6 months, up to 5 yearsPopulation: All randomized patients.
Overall survival
Outcome measures
| Measure |
Paclitaxel + Placebo
n=52 Participants
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Placebo PO daily
|
Paclitaxel + Pazopanib
n=54 Participants
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Pazopanib 800 mg PO daily
|
|---|---|---|
|
Overall Survival (OS)
|
23.3 months
Interval 17.3 to
There are not enough deaths to determine the upper bound of the 90% confidence interval using the method provided by SAS.
|
20.7 months
Interval 17.0 to 22.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsAnalyzed using deoxyribonucleic acid isolated from whole blood specimens.
Outcome measures
Outcome data not reported
Adverse Events
Paclitaxel + Placebo
Serious events: 15 serious events
Other events: 50 other events
Deaths: 20 deaths
Paclitaxel + Pazopanib
Serious events: 22 serious events
Other events: 51 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Paclitaxel + Placebo
n=50 participants at risk
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Placebo PO daily
|
Paclitaxel + Pazopanib
n=52 participants at risk
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Pazopanib 800 mg PO daily
|
|---|---|---|
|
Cardiac disorders
Cardiac Disorders - Other
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Eye disorders
Optic Nerve Disorder
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Colonic Perforation
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
3/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Small Intestinal Perforation
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Mucositis Oral
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Ileal Obstruction
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Ascites
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
General disorders
Pain
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
General disorders
Multi-Organ Failure
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
General disorders
Sudden Death Nos
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Infections and infestations
Sepsis
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Infections and infestations
Bronchial Infection
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Infections and infestations
Appendicitis
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Investigations
Neutrophil Count Decreased
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
9.6%
5/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Nervous system disorders
Syncope
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Vascular disorders
Thromboembolic Event
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Vascular disorders
Hypertension
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
Other adverse events
| Measure |
Paclitaxel + Placebo
n=50 participants at risk
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Placebo PO daily
|
Paclitaxel + Pazopanib
n=52 participants at risk
Paclitaxel 80 mg/m2 administered weekly on days 1, 8 and 15 with Pazopanib 800 mg PO daily
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Cardiac disorders
Sinus Bradycardia
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
6.0%
3/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Blood and lymphatic system disorders
Anemia
|
92.0%
46/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
92.3%
48/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Cardiac disorders
Palpitations
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
5.8%
3/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Cardiac disorders
Left Ventricular Systolic Dysfunction
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Cardiac disorders
Sinus Tachycardia
|
6.0%
3/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Cardiac disorders
Chest Pain - Cardiac
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Eye disorders
Eye Disorders - Other
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Eye disorders
Watering Eyes
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
5.8%
3/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Eye disorders
Cataract
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Eye disorders
Blurred Vision
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
5.8%
3/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Eye disorders
Dry Eye
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
5.8%
3/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Duodenal Stenosis
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.0%
6/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
7.7%
4/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Dry Mouth
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
7.7%
4/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Constipation
|
54.0%
27/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
44.2%
23/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
30.0%
15/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
67.3%
35/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
10/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
42.3%
22/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Bloating
|
10.0%
5/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
9.6%
5/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Stomach Pain
|
8.0%
4/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
7.7%
4/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Anal Hemorrhage
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Abdominal Pain
|
48.0%
24/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
40.4%
21/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
6.0%
3/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Oral Dysesthesia
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Mucositis Oral
|
12.0%
6/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
26.9%
14/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Oral Hemorrhage
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Ileus
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Gingival Pain
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Oral Pain
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
7.7%
4/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Oral Cavity Fistula
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Abdominal Distension
|
10.0%
5/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
5.8%
3/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Nausea
|
60.0%
30/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
69.2%
36/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
7.7%
4/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Hemorrhoidal Hemorrhage
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
5.8%
3/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Esophageal Stenosis
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Ascites
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
9.6%
5/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Toothache
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Gastrointestinal disorders
Flatulence
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
5.8%
3/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
General disorders
Pain
|
18.0%
9/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
17.3%
9/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
General disorders
Malaise
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
5.8%
3/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
General disorders
Localized Edema
|
6.0%
3/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
General disorders
Flu Like Symptoms
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
General disorders
Non-Cardiac Chest Pain
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
General disorders
Edema Limbs
|
14.0%
7/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
15.4%
8/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
General disorders
Edema Face
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
General disorders
Fatigue
|
78.0%
39/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
75.0%
39/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
General disorders
Fever
|
6.0%
3/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
9.6%
5/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
General disorders
Gait Disturbance
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
7.7%
4/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
General disorders
Chills
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
General disorders
Infusion Related Reaction
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Immune system disorders
Allergic Reaction
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Infections and infestations
Upper Respiratory Infection
|
6.0%
3/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
7.7%
4/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Infections and infestations
Tooth Infection
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Infections and infestations
Vulval Infection
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Infections and infestations
Skin Infection
|
6.0%
3/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
5.8%
3/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Infections and infestations
Sinusitis
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
5.8%
3/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Infections and infestations
Sepsis
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Infections and infestations
Nail Infection
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Infections and infestations
Mucosal Infection
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Infections and infestations
Lung Infection
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Infections and infestations
Kidney Infection
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Infections and infestations
Gum Infection
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Infections and infestations
Urinary Tract Infection
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
9.6%
5/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Infections and infestations
Catheter Related Infection
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Infections and infestations
Breast Infection
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Infections and infestations
Lip Infection
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Infections and infestations
Abdominal Infection
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Injury, poisoning and procedural complications
Prolapse Of Intestinal Stoma
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Injury, poisoning and procedural complications
Wound Complication
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Injury, poisoning and procedural complications
Bruising
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Investigations
Investigations - Other
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Investigations
Weight Loss
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
11.5%
6/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Investigations
Weight Gain
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
5.8%
3/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Investigations
Serum Amylase Increased
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Investigations
Platelet Count Decreased
|
20.0%
10/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
46.2%
24/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Investigations
Lymphocyte Count Decreased
|
18.0%
9/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
26.9%
14/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Investigations
Lipase Increased
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Investigations
Inr Increased
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Investigations
Ggt Increased
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Investigations
Electrocardiogram Qt Corrected Interval Prolonged
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Investigations
Creatinine Increased
|
10.0%
5/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
19.2%
10/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Investigations
Cholesterol High
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Investigations
Neutrophil Count Decreased
|
46.0%
23/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
82.7%
43/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Investigations
Cardiac Troponin I Increased
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Investigations
Cpk Increased
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Investigations
Blood Bilirubin Increased
|
8.0%
4/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
11.5%
6/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Investigations
White Blood Cell Decreased
|
70.0%
35/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
90.4%
47/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Investigations
Aspartate Aminotransferase Increased
|
6.0%
3/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
34.6%
18/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Investigations
Alkaline Phosphatase Increased
|
12.0%
6/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
26.9%
14/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Investigations
Alanine Aminotransferase Increased
|
14.0%
7/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
38.5%
20/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Metabolism and nutrition disorders
Metabolism And Nutrition Disorders - Other
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Metabolism and nutrition disorders
Iron Overload
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.0%
5/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
15.4%
8/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.0%
7/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
23.1%
12/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
24.0%
12/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
36.5%
19/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.0%
11/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
32.7%
17/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
8.0%
4/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.0%
8/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
23.1%
12/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.0%
7/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
23.1%
12/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
6.0%
3/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.0%
3/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
7.7%
4/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
34.0%
17/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
40.4%
21/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Metabolism and nutrition disorders
Glucose Intolerance
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
15.4%
8/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
24.0%
12/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
38.5%
20/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
10.0%
5/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.0%
9/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
26.9%
14/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Trunk
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
11.5%
6/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
20.0%
10/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
21.2%
11/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.0%
6/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
15.4%
8/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Disorder -
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Nervous system disorders
Tremor
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Nervous system disorders
Transient Ischemic Attacks
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
54.0%
27/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
51.9%
27/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
10.0%
5/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
9.6%
5/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Nervous system disorders
Paresthesia
|
12.0%
6/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Nervous system disorders
Memory Impairment
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Nervous system disorders
Headache
|
26.0%
13/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
32.7%
17/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Nervous system disorders
Dysgeusia
|
14.0%
7/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
15.4%
8/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Nervous system disorders
Dysesthesia
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Nervous system disorders
Syncope
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Nervous system disorders
Dizziness
|
12.0%
6/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
26.9%
14/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Nervous system disorders
Concentration Impairment
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Nervous system disorders
Cognitive Disturbance
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Psychiatric disorders
Insomnia
|
16.0%
8/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
25.0%
13/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Psychiatric disorders
Depression
|
6.0%
3/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
17.3%
9/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Psychiatric disorders
Confusion
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Psychiatric disorders
Anxiety
|
18.0%
9/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
17.3%
9/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Renal and urinary disorders
Urine Discoloration
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Renal and urinary disorders
Urinary Urgency
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Renal and urinary disorders
Urinary Incontinence
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Renal and urinary disorders
Urinary Tract Pain
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Renal and urinary disorders
Urinary Frequency
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Renal and urinary disorders
Renal Calculi
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Renal and urinary disorders
Proteinuria
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
7.7%
4/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Renal and urinary disorders
Hematuria
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Renal and urinary disorders
Cystitis Noninfective
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Reproductive system and breast disorders
Vaginal Pain
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Reproductive system and breast disorders
Breast Pain
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic And Mediastinal Disorders -
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Voice Alteration
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
6.0%
3/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
6.0%
3/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
11.5%
6/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Inflammation
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Hemorrhage
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
5.8%
3/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.0%
7/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
25.0%
13/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
42.0%
21/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
38.5%
20/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.0%
11/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
15.4%
8/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary Hemorrhage
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
6.0%
3/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
5.8%
3/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.0%
4/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
7.7%
4/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia Syndrome
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
5.8%
3/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Pain Of Skin
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
18.0%
9/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
15.4%
8/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin Hypopigmentation
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
5.8%
3/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Nail Ridging
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
7.7%
4/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Nail Discoloration
|
8.0%
4/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
11.5%
6/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
2.0%
1/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
0.00%
0/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
58.0%
29/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
46.2%
24/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Surgical and medical procedures
Surgical And Medical Procedures - Other
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Vascular disorders
Thromboembolic Event
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Vascular disorders
Lymphedema
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Vascular disorders
Hypotension
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
5.8%
3/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Vascular disorders
Hypertension
|
20.0%
10/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
55.8%
29/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Vascular disorders
Hot Flashes
|
6.0%
3/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
5.8%
3/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Vascular disorders
Hematoma
|
0.00%
0/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
1.9%
1/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
|
Vascular disorders
Flushing
|
4.0%
2/50 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
3.8%
2/52 • Every 28 days (1cycle) while on study treatment. Up to 30 days after treatment ends, up to 5 years.
|
Additional Information
Linda Gedeon on behalf of Michael Sill, PhD.
NRG Oncology
Phone: 716-845-1169
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60