Trial Outcomes & Findings for Temsirolimus, Carboplatin, and Paclitaxel as First-Line Therapy in Treating Patients With Newly Diagnosed Stage III-IV Clear Cell Ovarian Cancer (NCT NCT01196429)
NCT ID: NCT01196429
Last Updated: 2019-08-08
Results Overview
Progression of target lesions (TL) was a \>=20% increase in the sum of the diameters of TL, taking as reference the smallest sum on study (including the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must demonstrate an absolute increase \>=5 mm. Progression of non-target lesions (NTL) as defined as appearance of \>=1 new lesions or unequivocal progression of existing NTL. Unequivocal progression should not normally trump target lesion status; it must be representative of overall disease status change, not a single lesion increase. Clear progression of only NTL is exceptional, but the opinion of the treating physician should prevail in such circumstances, and the progression status should be later confirmed by a review panel (or Principal Investigator). Progression of TL, unequivocal progression of NTL, or new lesions constitutes progression. This description is abbreviated; see the RECIST 1.1 manuscript for further details.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
Tumor scans were done every other cycle for the first 6 months; then every 3 months x2; then every 6 months thereafter; and at any other time if clinically indicated or signs suggestive of progressive disease or rising levels; for up to 5 years.
Results posted on
2019-08-08
Participant Flow
The study was activated on 8/30/2010 and closed to accrual on 1/6/2014.
Additional details about the interventions administered were not included because these are groups (not arms).
Participant milestones
| Measure |
US/Korea
Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
|
Japan
Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
42
|
45
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
US/Korea
Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
|
Japan
Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
|
|---|---|---|
|
Overall Study
Ineligible - inadequate pathology
|
1
|
0
|
|
Overall Study
Ineligible - wrong cell type
|
1
|
0
|
|
Overall Study
Refused - Never Treated
|
1
|
0
|
Baseline Characteristics
Temsirolimus, Carboplatin, and Paclitaxel as First-Line Therapy in Treating Patients With Newly Diagnosed Stage III-IV Clear Cell Ovarian Cancer
Baseline characteristics by cohort
| Measure |
US/Korea
n=42 Participants
Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
|
Japan
n=45 Participants
Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
20-29 years
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Age, Customized
30-39 years
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Age, Customized
40-49 years
|
12 participants
n=99 Participants
|
9 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Age, Customized
50-59 years
|
21 participants
n=99 Participants
|
21 participants
n=107 Participants
|
42 participants
n=206 Participants
|
|
Age, Customized
60-69 years
|
6 participants
n=99 Participants
|
8 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Age, Customized
70-79 years
|
0 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Age, Customized
80-89 years
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Tumor scans were done every other cycle for the first 6 months; then every 3 months x2; then every 6 months thereafter; and at any other time if clinically indicated or signs suggestive of progressive disease or rising levels; for up to 5 years.Population: Eligible and Treated Patients
Progression of target lesions (TL) was a \>=20% increase in the sum of the diameters of TL, taking as reference the smallest sum on study (including the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must demonstrate an absolute increase \>=5 mm. Progression of non-target lesions (NTL) as defined as appearance of \>=1 new lesions or unequivocal progression of existing NTL. Unequivocal progression should not normally trump target lesion status; it must be representative of overall disease status change, not a single lesion increase. Clear progression of only NTL is exceptional, but the opinion of the treating physician should prevail in such circumstances, and the progression status should be later confirmed by a review panel (or Principal Investigator). Progression of TL, unequivocal progression of NTL, or new lesions constitutes progression. This description is abbreviated; see the RECIST 1.1 manuscript for further details.
Outcome measures
| Measure |
US/Korea
n=42 Participants
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
|
Japan
n=45 Participants
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
|
|---|---|---|
|
Proportion of Patients Who Are Alive and Progression-free for at Least 12 Months After Study Entry in Patients With Newly Diagnosed Stage III or IV Clear Cell Ovarian Cancer in the Following Populations: Patients in the U.S./Worldwide and Japan
|
43 percentage of participants
Interval 31.0 to 55.0
|
53 percentage of participants
Interval 41.0 to 65.0
|
PRIMARY outcome
Timeframe: Tumor scans were done every other cycle for the first 6 months;then every 3 mnths x2;then every 6 mnths thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggesting progressive dx or rising serum tumor marker lePopulation: The protocol stated "if the combination is declared active (i.e., HO is rejected) in one or both of the populations, the two populations will be compared with respect to PFS using a logrank test stratified by optimal/suboptimal disease status". The combination was not declared active in either population.
Progression-free survival (PFS) was defined s the period from study entry until disease progression, death, or the last date of contact. Progression was based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Outcome measure data not reported because protocol stated "If the combination is declared active (i.e. HO is rejected) in one or both of the populations, the two populations will be compared with respect to PFS using a logrank test stratified by optimal/suboptimal disease status." The combination was not declared active in either population.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Each cycle while on treatmentPopulation: Eligible and Treated Patients
Grade 3 or higher adverse events were graded by CTC AE v4
Outcome measures
| Measure |
US/Korea
n=42 Participants
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
|
Japan
n=45 Participants
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
|
|---|---|---|
|
Frequency and Severity of Toxicity
Neutrophil count decreased
|
36 participants
|
42 participants
|
|
Frequency and Severity of Toxicity
White blood cell decreased
|
27 participants
|
32 participants
|
|
Frequency and Severity of Toxicity
Anemia
|
9 participants
|
13 participants
|
|
Frequency and Severity of Toxicity
Platelet count decreased
|
10 participants
|
10 participants
|
|
Frequency and Severity of Toxicity
Hypertension
|
4 participants
|
10 participants
|
|
Frequency and Severity of Toxicity
hypertriglyceridemia
|
6 participants
|
7 participants
|
|
Frequency and Severity of Toxicity
Mucositis oral
|
5 participants
|
5 participants
|
|
Frequency and Severity of Toxicity
Febrile neutropenia
|
4 participants
|
5 participants
|
|
Frequency and Severity of Toxicity
Diarrhea
|
6 participants
|
2 participants
|
|
Frequency and Severity of Toxicity
Hypokalemia
|
3 participants
|
4 participants
|
|
Frequency and Severity of Toxicity
Hyperglycemia
|
4 participants
|
2 participants
|
|
Frequency and Severity of Toxicity
Abdominal pain
|
3 participants
|
1 participants
|
|
Frequency and Severity of Toxicity
Lymphocyte count decreased
|
2 participants
|
2 participants
|
|
Frequency and Severity of Toxicity
Nausea
|
1 participants
|
2 participants
|
|
Frequency and Severity of Toxicity
Urinary tract infection
|
3 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
GGT increased
|
0 participants
|
3 participants
|
|
Frequency and Severity of Toxicity
Edema limbs
|
2 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Fatigue
|
1 participants
|
1 participants
|
|
Frequency and Severity of Toxicity
Fever
|
1 participants
|
1 participants
|
|
Frequency and Severity of Toxicity
Non-cardiac chest pain
|
2 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Cholesterol high
|
0 participants
|
2 participants
|
|
Frequency and Severity of Toxicity
Weight gain
|
2 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Hypoalbuminemia
|
1 participants
|
1 participants
|
|
Frequency and Severity of Toxicity
Hyponatremia
|
2 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Hypophosphatemia
|
0 participants
|
2 participants
|
|
Frequency and Severity of Toxicity
Peripheral Sensory neuropathy
|
0 participants
|
2 participants
|
|
Frequency and Severity of Toxicity
Cough
|
2 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Dyspnea
|
2 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Pharyngeal mucositis
|
0 participants
|
2 participants
|
|
Frequency and Severity of Toxicity
Rash maculo-papular
|
1 participants
|
1 participants
|
|
Frequency and Severity of Toxicity
Colonic perforation
|
0 participants
|
1 participants
|
|
Frequency and Severity of Toxicity
Constipation
|
1 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Ileus
|
1 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Oral pain
|
1 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Small intestinal obstruction
|
1 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Vomiting
|
1 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Pain
|
1 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Cholecystitis
|
1 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Hepatobiliary disorders-other
|
0 participants
|
1 participants
|
|
Frequency and Severity of Toxicity
Appendicitis perforated
|
0 participants
|
1 participants
|
|
Frequency and Severity of Toxicity
Kidney infection
|
1 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Lung infection
|
1 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Peripherl nerve infection
|
1 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Pharyngitis
|
0 participants
|
1 participants
|
|
Frequency and Severity of Toxicity
Skin infection
|
1 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Infections and infestations -other
|
1 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Alanine aminotransferase increased
|
0 participants
|
1 participants
|
|
Frequency and Severity of Toxicity
Aspartate aminotransferase increased
|
0 participants
|
1 participants
|
|
Frequency and Severity of Toxicity
Creatiine increased
|
0 participants
|
1 participants
|
|
Frequency and Severity of Toxicity
Anorexia
|
0 participants
|
1 participants
|
|
Frequency and Severity of Toxicity
Dehydration
|
1 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Hypermagnesemia
|
0 participants
|
1 participants
|
|
Frequency and Severity of Toxicity
Back Pain
|
1 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Bone Pain
|
1 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Flank pain
|
1 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Pain in Extremity
|
1 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Dizziness
|
0 participants
|
1 participants
|
|
Frequency and Severity of Toxicity
Paresthesia
|
1 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Vasovagal reaction
|
1 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Anxiety
|
1 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Dysparenuia
|
1 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Pneumonitis
|
0 participants
|
1 participants
|
|
Frequency and Severity of Toxicity
Sore throat
|
1 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Hypotension
|
1 participants
|
0 participants
|
|
Frequency and Severity of Toxicity
Lymphocele
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Tumor scans were done every other cycle for the first 6 months; then every 3 months x 2; then every 6 mths thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising tumor markPopulation: Eligible and Treated Patients
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1
Outcome measures
| Measure |
US/Korea
n=42 Participants
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
|
Japan
n=45 Participants
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
|
|---|---|---|
|
Progression-free Survival
|
11.0 months
Interval 6.1 to 14.3
|
12.1 months
Interval 9.5 to 16.6
|
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 for the next 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 |
US/Korea
n=42 Participants
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
|
Japan
n=45 Participants
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
|
|---|---|---|
|
Overall Survival
|
22.6 months
Interval 19.2 to 36.3
|
25.6 months
Interval 21.4 to
Not reached, but is \>37.1 months.
|
SECONDARY outcome
Timeframe: Every other cycle for first 6 months; then every 3 months for two years; then every six months for the next three years; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tuPopulation: Eligible and Treated Patients
Complete and Partial Tumor Response by RECIST 1.1. RECIST1.1 is a multi-page paper, and response is defined in the protocol across multiple pages, so it is not practical to define response here.
Outcome measures
| Measure |
US/Korea
n=42 Participants
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
|
Japan
n=45 Participants
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
|
|---|---|---|
|
Objective Tumor Response
|
54 percentage of participants
Interval 32.0 to 74.0
|
71 percentage of participants
Interval 51.0 to 85.0
|
Adverse Events
US/Korea
Serious events: 11 serious events
Other events: 42 other events
Deaths: 0 deaths
Japan
Serious events: 8 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
US/Korea
n=42 participants at risk
Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
|
Japan
n=45 participants at risk
Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.8%
2/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Gastrointestinal disorders
Mucositis Oral
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
General disorders
Non-Cardiac Chest Pain
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
General disorders
Fever
|
2.4%
1/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Hepatobiliary disorders
Hepatobiliary Disorders - Other
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Hepatobiliary disorders
Cholecystitis
|
4.8%
2/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Infections and infestations
Kidney Infection
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Infections and infestations
Urinary Tract Infection
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Infections and infestations
Appendicitis Perforated
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/42 • Study Treatment
|
4.4%
2/45 • Study Treatment
|
|
Investigations
Neutrophil Count Decreased
|
11.9%
5/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Investigations
White Blood Cell Decreased
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
4.8%
2/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Nervous system disorders
Dizziness
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Mucositis
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
Other adverse events
| Measure |
US/Korea
n=42 participants at risk
Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
|
Japan
n=45 participants at risk
Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
42/42 • Study Treatment
|
100.0%
45/45 • Study Treatment
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
7.1%
3/42 • Study Treatment
|
11.1%
5/45 • Study Treatment
|
|
Cardiac disorders
Atrial Fibrillation
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Cardiac disorders
Palpitations
|
7.1%
3/42 • Study Treatment
|
8.9%
4/45 • Study Treatment
|
|
Cardiac disorders
Sinus Tachycardia
|
7.1%
3/42 • Study Treatment
|
6.7%
3/45 • Study Treatment
|
|
Cardiac disorders
Chest Pain - Cardiac
|
0.00%
0/42 • Study Treatment
|
6.7%
3/45 • Study Treatment
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/42 • Study Treatment
|
4.4%
2/45 • Study Treatment
|
|
Ear and labyrinth disorders
Tinnitus
|
21.4%
9/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Nervous system disorders
Tremor
|
4.8%
2/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Ear and labyrinth disorders
Hearing Impaired
|
4.8%
2/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Ear and labyrinth disorders
Ear Pain
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Endocrine disorders
Hypothyroidism
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Endocrine disorders
Hypoparathyroidism
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Eye disorders
Watering Eyes
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/42 • Study Treatment
|
15.6%
7/45 • Study Treatment
|
|
Eye disorders
Blurred Vision
|
19.0%
8/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Eye disorders
Dry Eye
|
4.8%
2/42 • Study Treatment
|
4.4%
2/45 • Study Treatment
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
7/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
19.0%
8/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Gastrointestinal disorders
Colonic Perforation
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Gastrointestinal disorders
Colitis
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Gastrointestinal disorders
Constipation
|
45.2%
19/42 • Study Treatment
|
46.7%
21/45 • Study Treatment
|
|
Gastrointestinal disorders
Diarrhea
|
57.1%
24/42 • Study Treatment
|
57.8%
26/45 • Study Treatment
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/42 • Study Treatment
|
6.7%
3/45 • Study Treatment
|
|
Gastrointestinal disorders
Vomiting
|
38.1%
16/42 • Study Treatment
|
40.0%
18/45 • Study Treatment
|
|
Gastrointestinal disorders
Bloating
|
9.5%
4/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Gastrointestinal disorders
Stomach Pain
|
0.00%
0/42 • Study Treatment
|
17.8%
8/45 • Study Treatment
|
|
Gastrointestinal disorders
Anal Mucositis
|
4.8%
2/42 • Study Treatment
|
4.4%
2/45 • Study Treatment
|
|
Gastrointestinal disorders
Rectal Mucositis
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Gastrointestinal disorders
Abdominal Pain
|
40.5%
17/42 • Study Treatment
|
17.8%
8/45 • Study Treatment
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
4.8%
2/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Gastrointestinal disorders
Oral Dysesthesia
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Gastrointestinal disorders
Mucositis Oral
|
59.5%
25/42 • Study Treatment
|
88.9%
40/45 • Study Treatment
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other
|
4.8%
2/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Gastrointestinal disorders
Anal Pain
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Gastrointestinal disorders
Oral Hemorrhage
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Gastrointestinal disorders
Ileus
|
2.4%
1/42 • Study Treatment
|
11.1%
5/45 • Study Treatment
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
2.4%
1/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Gastrointestinal disorders
Gingival Pain
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Gastrointestinal disorders
Oral Pain
|
9.5%
4/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Gastrointestinal disorders
Abdominal Distension
|
9.5%
4/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Gastrointestinal disorders
Nausea
|
66.7%
28/42 • Study Treatment
|
57.8%
26/45 • Study Treatment
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
4.8%
2/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Gastrointestinal disorders
Rectal Pain
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Gastrointestinal disorders
Hemorrhoidal Hemorrhage
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Gastrointestinal disorders
Hemorrhoids
|
4.8%
2/42 • Study Treatment
|
4.4%
2/45 • Study Treatment
|
|
Gastrointestinal disorders
Ascites
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/42 • Study Treatment
|
6.7%
3/45 • Study Treatment
|
|
Gastrointestinal disorders
Esophageal Pain
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Gastrointestinal disorders
Dental Caries
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Gastrointestinal disorders
Flatulence
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/42 • Study Treatment
|
6.7%
3/45 • Study Treatment
|
|
General disorders
General Disorders And Administration Site Conditio
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
General disorders
Pain
|
23.8%
10/42 • Study Treatment
|
6.7%
3/45 • Study Treatment
|
|
General disorders
Malaise
|
4.8%
2/42 • Study Treatment
|
53.3%
24/45 • Study Treatment
|
|
General disorders
Localized Edema
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
General disorders
Injection Site Reaction
|
2.4%
1/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
General disorders
Infusion Site Extravasation
|
0.00%
0/42 • Study Treatment
|
13.3%
6/45 • Study Treatment
|
|
General disorders
Flu Like Symptoms
|
9.5%
4/42 • Study Treatment
|
31.1%
14/45 • Study Treatment
|
|
General disorders
Edema Trunk
|
2.4%
1/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
General disorders
Non-Cardiac Chest Pain
|
9.5%
4/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
General disorders
Edema Limbs
|
28.6%
12/42 • Study Treatment
|
48.9%
22/45 • Study Treatment
|
|
General disorders
Facial Pain
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
General disorders
Edema Face
|
9.5%
4/42 • Study Treatment
|
15.6%
7/45 • Study Treatment
|
|
General disorders
Fatigue
|
85.7%
36/42 • Study Treatment
|
42.2%
19/45 • Study Treatment
|
|
General disorders
Fever
|
19.0%
8/42 • Study Treatment
|
17.8%
8/45 • Study Treatment
|
|
General disorders
Gait Disturbance
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
General disorders
Chills
|
16.7%
7/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
General disorders
Infusion Related Reaction
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Hepatobiliary disorders
Cholecystitis
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Immune system disorders
Allergic Reaction
|
7.1%
3/42 • Study Treatment
|
6.7%
3/45 • Study Treatment
|
|
Infections and infestations
Infections And Infestations - Other
|
7.1%
3/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Infections and infestations
Upper Respiratory Infection
|
9.5%
4/42 • Study Treatment
|
11.1%
5/45 • Study Treatment
|
|
Infections and infestations
Vulval Infection
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Infections and infestations
Skin Infection
|
7.1%
3/42 • Study Treatment
|
8.9%
4/45 • Study Treatment
|
|
Infections and infestations
Sinusitis
|
7.1%
3/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Infections and infestations
Rash Pustular
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/42 • Study Treatment
|
6.7%
3/45 • Study Treatment
|
|
Infections and infestations
Peripheral Nerve Infection
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Infections and infestations
Otitis Media
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Infections and infestations
Papulopustular Rash
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Infections and infestations
Nail Infection
|
4.8%
2/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Infections and infestations
Mucosal Infection
|
4.8%
2/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Infections and infestations
Lung Infection
|
4.8%
2/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Infections and infestations
Paronychia
|
0.00%
0/42 • Study Treatment
|
17.8%
8/45 • Study Treatment
|
|
Infections and infestations
Eye Infection
|
2.4%
1/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Infections and infestations
Small Intestine Infection
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Infections and infestations
Gum Infection
|
0.00%
0/42 • Study Treatment
|
4.4%
2/45 • Study Treatment
|
|
Infections and infestations
Vaginal Infection
|
4.8%
2/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Infections and infestations
Urinary Tract Infection
|
14.3%
6/42 • Study Treatment
|
4.4%
2/45 • Study Treatment
|
|
Infections and infestations
Bladder Infection
|
0.00%
0/42 • Study Treatment
|
11.1%
5/45 • Study Treatment
|
|
Infections and infestations
Lip Infection
|
2.4%
1/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
1/42 • Study Treatment
|
4.4%
2/45 • Study Treatment
|
|
Injury, poisoning and procedural complications
Wound Complication
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Injury, poisoning and procedural complications
Bruising
|
4.8%
2/42 • Study Treatment
|
4.4%
2/45 • Study Treatment
|
|
Investigations
Weight Loss
|
19.0%
8/42 • Study Treatment
|
31.1%
14/45 • Study Treatment
|
|
Investigations
Weight Gain
|
23.8%
10/42 • Study Treatment
|
22.2%
10/45 • Study Treatment
|
|
Investigations
Serum Amylase Increased
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Investigations
Platelet Count Decreased
|
92.9%
39/42 • Study Treatment
|
91.1%
41/45 • Study Treatment
|
|
Investigations
Lymphocyte Count Decreased
|
11.9%
5/42 • Study Treatment
|
4.4%
2/45 • Study Treatment
|
|
Investigations
Inr Increased
|
0.00%
0/42 • Study Treatment
|
4.4%
2/45 • Study Treatment
|
|
Investigations
Ggt Increased
|
0.00%
0/42 • Study Treatment
|
20.0%
9/45 • Study Treatment
|
|
Investigations
Creatinine Increased
|
4.8%
2/42 • Study Treatment
|
15.6%
7/45 • Study Treatment
|
|
Investigations
Cholesterol High
|
52.4%
22/42 • Study Treatment
|
66.7%
30/45 • Study Treatment
|
|
Investigations
Neutrophil Count Decreased
|
100.0%
42/42 • Study Treatment
|
97.8%
44/45 • Study Treatment
|
|
Investigations
Cpk Increased
|
0.00%
0/42 • Study Treatment
|
4.4%
2/45 • Study Treatment
|
|
Investigations
Blood Bilirubin Increased
|
2.4%
1/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Investigations
White Blood Cell Decreased
|
100.0%
42/42 • Study Treatment
|
100.0%
45/45 • Study Treatment
|
|
Investigations
Aspartate Aminotransferase Increased
|
23.8%
10/42 • Study Treatment
|
35.6%
16/45 • Study Treatment
|
|
Investigations
Alkaline Phosphatase Increased
|
26.2%
11/42 • Study Treatment
|
24.4%
11/45 • Study Treatment
|
|
Investigations
Alanine Aminotransferase Increased
|
28.6%
12/42 • Study Treatment
|
28.9%
13/45 • Study Treatment
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
0.00%
0/42 • Study Treatment
|
4.4%
2/45 • Study Treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.9%
5/42 • Study Treatment
|
6.7%
3/45 • Study Treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
21.4%
9/42 • Study Treatment
|
6.7%
3/45 • Study Treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
38.1%
16/42 • Study Treatment
|
4.4%
2/45 • Study Treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
42.9%
18/42 • Study Treatment
|
11.1%
5/45 • Study Treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
7.1%
3/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
19.0%
8/42 • Study Treatment
|
6.7%
3/45 • Study Treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
21.4%
9/42 • Study Treatment
|
17.8%
8/45 • Study Treatment
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
54.8%
23/42 • Study Treatment
|
68.9%
31/45 • Study Treatment
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.1%
3/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/42 • Study Treatment
|
6.7%
3/45 • Study Treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.4%
1/42 • Study Treatment
|
4.4%
2/45 • Study Treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
45.2%
19/42 • Study Treatment
|
48.9%
22/45 • Study Treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
7/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
47.6%
20/42 • Study Treatment
|
66.7%
30/45 • Study Treatment
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
31.0%
13/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.6%
12/42 • Study Treatment
|
60.0%
27/45 • Study Treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Upper Limb
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
4.8%
2/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Musculoskeletal and connective tissue disorders
Joint Range Of Motion Decreased
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
9.5%
4/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
14.3%
6/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
4.8%
2/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
11.9%
5/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.3%
6/42 • Study Treatment
|
15.6%
7/45 • Study Treatment
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.8%
2/42 • Study Treatment
|
6.7%
3/45 • Study Treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
14/42 • Study Treatment
|
55.6%
25/45 • Study Treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Disorder -
|
2.4%
1/42 • Study Treatment
|
4.4%
2/45 • Study Treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Incl
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
0.00%
0/42 • Study Treatment
|
4.4%
2/45 • Study Treatment
|
|
Nervous system disorders
Vasovagal Reaction
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Nervous system disorders
Somnolence
|
0.00%
0/42 • Study Treatment
|
6.7%
3/45 • Study Treatment
|
|
Nervous system disorders
Presyncope
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
66.7%
28/42 • Study Treatment
|
95.6%
43/45 • Study Treatment
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
7.1%
3/42 • Study Treatment
|
11.1%
5/45 • Study Treatment
|
|
Nervous system disorders
Paresthesia
|
14.3%
6/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Nervous system disorders
Neuralgia
|
4.8%
2/42 • Study Treatment
|
4.4%
2/45 • Study Treatment
|
|
Nervous system disorders
Memory Impairment
|
4.8%
2/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Nervous system disorders
Movements Involuntary
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Nervous system disorders
Headache
|
35.7%
15/42 • Study Treatment
|
22.2%
10/45 • Study Treatment
|
|
Nervous system disorders
Dysgeusia
|
11.9%
5/42 • Study Treatment
|
53.3%
24/45 • Study Treatment
|
|
Nervous system disorders
Sinus Pain
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Nervous system disorders
Dysesthesia
|
2.4%
1/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Nervous system disorders
Dizziness
|
16.7%
7/42 • Study Treatment
|
4.4%
2/45 • Study Treatment
|
|
Nervous system disorders
Cognitive Disturbance
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Nervous system disorders
Ataxia
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Psychiatric disorders
Personality Change
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Psychiatric disorders
Restlessness
|
4.8%
2/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Psychiatric disorders
Libido Decreased
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Psychiatric disorders
Insomnia
|
31.0%
13/42 • Study Treatment
|
24.4%
11/45 • Study Treatment
|
|
Psychiatric disorders
Depression
|
21.4%
9/42 • Study Treatment
|
4.4%
2/45 • Study Treatment
|
|
Psychiatric disorders
Confusion
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Psychiatric disorders
Anxiety
|
33.3%
14/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Psychiatric disorders
Anorgasmia
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Renal and urinary disorders
Urinary Urgency
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Renal and urinary disorders
Urinary Incontinence
|
4.8%
2/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Renal and urinary disorders
Urinary Tract Pain
|
16.7%
7/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Renal and urinary disorders
Urinary Frequency
|
16.7%
7/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Renal and urinary disorders
Renal Calculi
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Renal and urinary disorders
Proteinuria
|
4.8%
2/42 • Study Treatment
|
8.9%
4/45 • Study Treatment
|
|
Renal and urinary disorders
Hematuria
|
2.4%
1/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Renal and urinary disorders
Cystitis Noninfective
|
0.00%
0/42 • Study Treatment
|
6.7%
3/45 • Study Treatment
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Reproductive system and breast disorders
Vaginal Pain
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
4.8%
2/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Reproductive system and breast disorders
Pelvic Pain
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Reproductive system and breast disorders
Vaginal Inflammation
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Reproductive system and breast disorders
Dyspareunia
|
9.5%
4/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic And Mediastinal Disorders -
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Respiratory, thoracic and mediastinal disorders
Voice Alteration
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
4.8%
2/42 • Study Treatment
|
6.7%
3/45 • Study Treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Disorder
|
4.8%
2/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
7.1%
3/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.4%
1/42 • Study Treatment
|
20.0%
9/45 • Study Treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.00%
0/42 • Study Treatment
|
4.4%
2/45 • Study Treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Mucositis
|
0.00%
0/42 • Study Treatment
|
17.8%
8/45 • Study Treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
14.3%
6/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Mucositis
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
2.4%
1/42 • Study Treatment
|
4.4%
2/45 • Study Treatment
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Inflammation
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.8%
2/42 • Study Treatment
|
4.4%
2/45 • Study Treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.5%
4/42 • Study Treatment
|
33.3%
15/45 • Study Treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
14/42 • Study Treatment
|
15.6%
7/45 • Study Treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.4%
9/42 • Study Treatment
|
11.1%
5/45 • Study Treatment
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
4.8%
2/42 • Study Treatment
|
6.7%
3/45 • Study Treatment
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other
|
4.8%
2/42 • Study Treatment
|
11.1%
5/45 • Study Treatment
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.8%
2/42 • Study Treatment
|
20.0%
9/45 • Study Treatment
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
9.5%
4/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Skin and subcutaneous tissue disorders
Skin Induration
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
2.4%
1/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Skin and subcutaneous tissue disorders
Skin Atrophy
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
33.3%
14/42 • Study Treatment
|
40.0%
18/45 • Study Treatment
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
7/42 • Study Treatment
|
26.7%
12/45 • Study Treatment
|
|
Skin and subcutaneous tissue disorders
Periorbital Edema
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia Syndrome
|
0.00%
0/42 • Study Treatment
|
8.9%
4/45 • Study Treatment
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
33.3%
14/42 • Study Treatment
|
40.0%
18/45 • Study Treatment
|
|
Skin and subcutaneous tissue disorders
Skin Hypopigmentation
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Skin and subcutaneous tissue disorders
Nail Ridging
|
4.8%
2/42 • Study Treatment
|
8.9%
4/45 • Study Treatment
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
0.00%
0/42 • Study Treatment
|
8.9%
4/45 • Study Treatment
|
|
Skin and subcutaneous tissue disorders
Nail Discoloration
|
7.1%
3/42 • Study Treatment
|
11.1%
5/45 • Study Treatment
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.8%
2/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
9.5%
4/42 • Study Treatment
|
13.3%
6/45 • Study Treatment
|
|
Skin and subcutaneous tissue disorders
Bullous Dermatitis
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
71.4%
30/42 • Study Treatment
|
86.7%
39/45 • Study Treatment
|
|
Vascular disorders
Vasculitis
|
0.00%
0/42 • Study Treatment
|
11.1%
5/45 • Study Treatment
|
|
Vascular disorders
Thromboembolic Event
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Vascular disorders
Lymphocele
|
2.4%
1/42 • Study Treatment
|
0.00%
0/45 • Study Treatment
|
|
Vascular disorders
Lymphedema
|
11.9%
5/42 • Study Treatment
|
15.6%
7/45 • Study Treatment
|
|
Vascular disorders
Hypotension
|
4.8%
2/42 • Study Treatment
|
4.4%
2/45 • Study Treatment
|
|
Vascular disorders
Hypertension
|
35.7%
15/42 • Study Treatment
|
55.6%
25/45 • Study Treatment
|
|
Vascular disorders
Hot Flashes
|
21.4%
9/42 • Study Treatment
|
8.9%
4/45 • Study Treatment
|
|
Vascular disorders
Hematoma
|
0.00%
0/42 • Study Treatment
|
2.2%
1/45 • Study Treatment
|
|
Vascular disorders
Flushing
|
2.4%
1/42 • Study Treatment
|
17.8%
8/45 • Study Treatment
|
Additional Information
Linda Gedeon for William Brady PhD
NRG Oncology Statistics and Data Management Center - Buffalo
Phone: 716-845-5702
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60