Trial Outcomes & Findings for Vorinostat, Carboplatin, and Paclitaxel in Treating Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NCT NCT00481078)

NCT ID: NCT00481078

Last Updated: 2014-10-30

Results Overview

Each patient will be assigned one of the following categories: 1) complete response, 2) partial response, 3) stable disease, 4) progressive disease, 5) early death from malignant disease, 6) early death from toxicity, 7) early death because of other cause, or 9) unknown (not assessable, insufficient data). Patients with confirmed CR or PR according to the RECIST criteria were considered to have responded to treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 94 participants
• Primary outcome timeframe: Assessed every two cycles
• Results posted on: 2014-10-30

Participant Flow

Participant milestones

Measure	Arm I (Vorinostat, Paclitaxel, Carboplatin) Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.	Arm II (Placebo, Paclitaxel, Carboplatin) Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
Overall Study STARTED	62	32
Overall Study COMPLETED	20	12
Overall Study NOT COMPLETED	42	20

Reasons for withdrawal

Measure	Arm I (Vorinostat, Paclitaxel, Carboplatin) Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.	Arm II (Placebo, Paclitaxel, Carboplatin) Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
Overall Study Progression of disease	11	11
Overall Study Adverse Event	15	3
Overall Study Death	5	3
Overall Study Intercurrent illness	1	0
Overall Study Withdrawal by Subject	7	1
Overall Study Information not available	1	0
Overall Study Received other treatment	2	1
Overall Study Brain metastasis	0	1

Baseline Characteristics

Vorinostat, Carboplatin, and Paclitaxel in Treating Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Arm 1 n=62 Participants Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.	Arm 2 n=32 Participants Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.	Total n=94 Participants Total of all reporting groups
Age, Continuous	64 years n=5 Participants	66.5 years n=7 Participants	65 years n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	12 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	20 Participants n=7 Participants	58 Participants n=5 Participants
Region of Enrollment United States	62 participants n=5 Participants	32 participants n=7 Participants	94 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed every two cycles

Each patient will be assigned one of the following categories: 1) complete response, 2) partial response, 3) stable disease, 4) progressive disease, 5) early death from malignant disease, 6) early death from toxicity, 7) early death because of other cause, or 9) unknown (not assessable, insufficient data).

Patients with confirmed CR or PR according to the RECIST criteria were considered to have responded to treatment.

Outcome measures

Measure	Arm I (Vorinostat, Paclitaxel, Carboplatin) n=62 Participants Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.	Arm II (Placebo, Paclitaxel, Carboplatin) n=32 Participants Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
Response Rate	34 percentage of responding patients Interval 22.0 to 47.0	12.5 percentage of responding patients Interval 4.0 to 29.0

SECONDARY outcome

Timeframe: Up to 1 year

Evaluated using the Kaplan-Meier method. Compared between arms using the log-rank test.

Outcome measures

Measure	Arm I (Vorinostat, Paclitaxel, Carboplatin) n=62 Participants Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.	Arm II (Placebo, Paclitaxel, Carboplatin) n=32 Participants Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
Progression-free Survival	6 Months Interval 4.3 to 6.9	4.1 Months Interval 1.9 to 5.5

SECONDARY outcome

Timeframe: Up to 1 year

Evaluated using the Kaplan-Meier method. Compared between arms using the log-rank test.

Outcome measures

Measure	Arm I (Vorinostat, Paclitaxel, Carboplatin) n=62 Participants Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.	Arm II (Placebo, Paclitaxel, Carboplatin) n=32 Participants Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
Overall Survival	13 Months Interval 9.7 to The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.	9.7 Months Interval 6.0 to 13.0

Adverse Events

Arm I (Vorinostat, Paclitaxel, Carboplatin)

Serious events: 29 serious events

Other events: 61 other events

Deaths: 0 deaths

Arm II (Placebo, Paclitaxel, Carboplatin)

Serious events: 10 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I (Vorinostat, Paclitaxel, Carboplatin) n=61 participants at risk Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.	Arm II (Placebo, Paclitaxel, Carboplatin) n=32 participants at risk Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
Blood and lymphatic system disorders Febrile neutropenia	3.3% 2/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Blood and lymphatic system disorders Hemoglobin decreased	3.3% 2/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Cardiac disorders Atrial fibrillation	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Cardiac disorders Atrial flutter	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Cardiac disorders Pericardial effusion	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Abdominal pain	1.6% 1/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Diarrhea	3.3% 2/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Nausea	4.9% 3/61 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Vomiting	4.9% 3/61 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Chills	0.00% 0/61 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Death	3.3% 2/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Disease progression	0.00% 0/61 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	9.4% 3/32 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Fatigue	3.3% 2/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Fever	0.00% 0/61 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Ill-defined disorder	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Sudden death	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Infections and infestations Pneumonia	6.6% 4/61 • Number of events 5 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	6.2% 2/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Infections and infestations Sepsis	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Cardiac troponin I increased	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations INR increased	0.00% 0/61 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Leukocyte count decreased	6.6% 4/61 • Number of events 5 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	6.2% 2/32 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Lymphocyte count decreased	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Neutrophil count decreased	9.8% 6/61 • Number of events 6 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	6.2% 2/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Platelet count decreased	11.5% 7/61 • Number of events 9 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Dehydration	6.6% 4/61 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Serum calcium decreased	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Serum phosphate decreased	3.3% 2/61 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Serum potassium decreased	6.6% 4/61 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Serum potassium increased	0.00% 0/61 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Serum sodium decreased	4.9% 3/61 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Serum triglycerides increased	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/61 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Bone pain	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Joint pain	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Muscle weakness	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Myalgia	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/61 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Nervous system disorders Intracranial hemorrhage	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Nervous system disorders Peripheral motor neuropathy	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Psychiatric disorders Confusion	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Psychiatric disorders Depression	0.00% 0/61 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Psychiatric disorders Personality change	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Psychiatric disorders Psychosis	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Renal and urinary disorders Urinary incontinence	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.3% 2/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	12.5% 4/32 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	4.9% 3/61 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Skin and subcutaneous tissue disorders Skin ulceration	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Vascular disorders Hypotension	3.3% 2/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	6.2% 2/32 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Vascular disorders Thrombosis	3.3% 2/61 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.

Other adverse events

Measure	Arm I (Vorinostat, Paclitaxel, Carboplatin) n=61 participants at risk Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.	Arm II (Placebo, Paclitaxel, Carboplatin) n=32 participants at risk Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
Blood and lymphatic system disorders Febrile neutropenia	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Blood and lymphatic system disorders Hemoglobin decreased	70.5% 43/61 • Number of events 126 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	65.6% 21/32 • Number of events 71 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Blood and lymphatic system disorders Hemolysis	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Cardiac disorders Atrial fibrillation	1.6% 1/61 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Cardiac disorders Cardiac disorder	0.00% 0/61 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Cardiac disorders Myocardial ischemia	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Cardiac disorders Palpitations	1.6% 1/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	6.2% 2/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Cardiac disorders Pericardial effusion	0.00% 0/61 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Cardiac disorders Sinus bradycardia	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Cardiac disorders Sinus tachycardia	4.9% 3/61 • Number of events 5 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	6.2% 2/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Cardiac disorders Supraventricular tachycardia	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Ear and labyrinth disorders Ear disorder	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Ear and labyrinth disorders Tinnitus	3.3% 2/61 • Number of events 7 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Eye disorders Diplopia	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Eye disorders Dry eye syndrome	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Eye disorders Eye disorder	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Eye disorders Vision blurred	3.3% 2/61 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	6.2% 2/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Eye disorders Watering eyes	3.3% 2/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Abdominal distension	3.3% 2/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Abdominal pain	9.8% 6/61 • Number of events 11 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	6.2% 2/32 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Constipation	37.7% 23/61 • Number of events 43 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	40.6% 13/32 • Number of events 26 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Diarrhea	32.8% 20/61 • Number of events 39 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	25.0% 8/32 • Number of events 20 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Dry mouth	3.3% 2/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	9.4% 3/32 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Dyspepsia	8.2% 5/61 • Number of events 7 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	9.4% 3/32 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Dysphagia	6.6% 4/61 • Number of events 7 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Ear, nose and throat examination abnormal	11.5% 7/61 • Number of events 9 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Esophagitis	0.00% 0/61 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Fecal incontinence	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Flatulence	6.6% 4/61 • Number of events 6 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Gastritis	1.6% 1/61 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Hemorrhoids	3.3% 2/61 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Lip pain	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	1.6% 1/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Mucositis oral	1.6% 1/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Nausea	60.7% 37/61 • Number of events 77 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	43.8% 14/32 • Number of events 30 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Oral pain	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Rectal hemorrhage	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Gastrointestinal disorders Vomiting	41.0% 25/61 • Number of events 36 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	15.6% 5/32 • Number of events 10 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Chest pain	14.8% 9/61 • Number of events 15 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	6.2% 2/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Chills	11.5% 7/61 • Number of events 8 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Death	8.2% 5/61 • Number of events 5 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	18.8% 6/32 • Number of events 6 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Disease progression	32.8% 20/61 • Number of events 20 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	43.8% 14/32 • Number of events 14 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Edema limbs	11.5% 7/61 • Number of events 19 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	15.6% 5/32 • Number of events 10 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Facial pain	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Fatigue	85.2% 52/61 • Number of events 115 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	65.6% 21/32 • Number of events 61 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Fever	13.1% 8/61 • Number of events 8 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	12.5% 4/32 • Number of events 5 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Gait abnormal	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders General symptom	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Hypothermia	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Injection site reaction	3.3% 2/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	9.4% 3/32 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Localized edema	1.6% 1/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
General disorders Pain	6.6% 4/61 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	6.2% 2/32 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Hepatobiliary disorders Portal hypertension	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Immune system disorders Hypersensitivity	0.00% 0/61 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	6.2% 2/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Infections and infestations Bladder infection	3.3% 2/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Infections and infestations Bronchitis	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Infections and infestations Gingival infection	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Infections and infestations Infection	3.3% 2/61 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Infections and infestations Mucosal infection	3.3% 2/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Infections and infestations Opportunistic infection	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Infections and infestations Penile infection	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Infections and infestations Pneumonia	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Infections and infestations Sinusitis	0.00% 0/61 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	6.2% 2/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Infections and infestations Skin infection	0.00% 0/61 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Infections and infestations Upper respiratory infection	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Infections and infestations Urinary tract infection	6.6% 4/61 • Number of events 5 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Injury, poisoning and procedural complications Bruising	1.6% 1/61 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Injury, poisoning and procedural complications Wound dehiscence	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Activated partial thromboplastin time prolonged	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Alanine aminotransferase increased	16.4% 10/61 • Number of events 15 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	12.5% 4/32 • Number of events 7 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Alkaline phosphatase increased	21.3% 13/61 • Number of events 28 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	21.9% 7/32 • Number of events 20 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Aspartate aminotransferase increased	14.8% 9/61 • Number of events 19 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	9.4% 3/32 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Bilirubin increased	8.2% 5/61 • Number of events 10 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Creatine phosphokinase increased	1.6% 1/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Creatinine increased	11.5% 7/61 • Number of events 21 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations INR increased	3.3% 2/61 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Laboratory test abnormal	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Leukocyte count decreased	45.9% 28/61 • Number of events 66 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	43.8% 14/32 • Number of events 31 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Lymphocyte count decreased	23.0% 14/61 • Number of events 43 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	21.9% 7/32 • Number of events 14 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Neutrophil count decreased	50.8% 31/61 • Number of events 60 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	53.1% 17/32 • Number of events 36 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Platelet count decreased	59.0% 36/61 • Number of events 87 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	46.9% 15/32 • Number of events 38 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Serum cholesterol increased	1.6% 1/61 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Investigations Weight loss	16.4% 10/61 • Number of events 16 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	12.5% 4/32 • Number of events 13 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Anorexia	57.4% 35/61 • Number of events 57 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	34.4% 11/32 • Number of events 24 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Blood bicarbonate decreased	8.2% 5/61 • Number of events 9 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Blood glucose increased	47.5% 29/61 • Number of events 79 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	46.9% 15/32 • Number of events 39 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Dehydration	16.4% 10/61 • Number of events 15 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	9.4% 3/32 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Serum albumin decreased	29.5% 18/61 • Number of events 36 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	18.8% 6/32 • Number of events 21 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Serum calcium decreased	27.9% 17/61 • Number of events 28 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	9.4% 3/32 • Number of events 6 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Serum calcium increased	8.2% 5/61 • Number of events 7 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	6.2% 2/32 • Number of events 5 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Serum glucose decreased	6.6% 4/61 • Number of events 7 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	6.2% 2/32 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Serum magnesium decreased	9.8% 6/61 • Number of events 15 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	6.2% 2/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Serum magnesium increased	3.3% 2/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Serum phosphate decreased	16.4% 10/61 • Number of events 21 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	9.4% 3/32 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Serum potassium decreased	21.3% 13/61 • Number of events 21 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	21.9% 7/32 • Number of events 17 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Serum potassium increased	6.6% 4/61 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	6.2% 2/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Serum sodium decreased	29.5% 18/61 • Number of events 36 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	28.1% 9/32 • Number of events 14 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Serum sodium increased	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	9.4% 3/32 • Number of events 8 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Metabolism and nutrition disorders Serum triglycerides increased	1.6% 1/61 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Arthritis	4.9% 3/61 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	6.2% 2/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Back pain	19.7% 12/61 • Number of events 17 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Bone pain	8.2% 5/61 • Number of events 6 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	12.5% 4/32 • Number of events 8 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Chest wall pain	3.3% 2/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	9.4% 3/32 • Number of events 5 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Joint pain	9.8% 6/61 • Number of events 8 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	18.8% 6/32 • Number of events 13 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Muscle weakness	13.1% 8/61 • Number of events 12 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	6.2% 2/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	3.3% 2/61 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	1.6% 1/61 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Myalgia	16.4% 10/61 • Number of events 20 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	18.8% 6/32 • Number of events 11 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/61 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Musculoskeletal and connective tissue disorders Pain in extremity	19.7% 12/61 • Number of events 21 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	6.2% 2/32 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Nervous system disorders Arachnoiditis	0.00% 0/61 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Nervous system disorders Ataxia	4.9% 3/61 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Nervous system disorders Cognitive disturbance	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Nervous system disorders Depressed level of consciousness	3.3% 2/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Nervous system disorders Dizziness	26.2% 16/61 • Number of events 23 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	18.8% 6/32 • Number of events 7 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Nervous system disorders Headache	9.8% 6/61 • Number of events 9 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	12.5% 4/32 • Number of events 6 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Nervous system disorders Memory impairment	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Nervous system disorders Neurological disorder NOS	1.6% 1/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Nervous system disorders Peripheral motor neuropathy	3.3% 2/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	6.2% 2/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Nervous system disorders Peripheral sensory neuropathy	47.5% 29/61 • Number of events 87 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	37.5% 12/32 • Number of events 33 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Nervous system disorders Phantom pain	0.00% 0/61 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Nervous system disorders Seizure	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Nervous system disorders Syncope	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Nervous system disorders Taste alteration	18.0% 11/61 • Number of events 23 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	12.5% 4/32 • Number of events 5 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Nervous system disorders Tremor	3.3% 2/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Psychiatric disorders Agitation	1.6% 1/61 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Psychiatric disorders Anxiety	6.6% 4/61 • Number of events 6 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	9.4% 3/32 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Psychiatric disorders Confusion	9.8% 6/61 • Number of events 11 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	9.4% 3/32 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Psychiatric disorders Depression	4.9% 3/61 • Number of events 5 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	9.4% 3/32 • Number of events 5 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Psychiatric disorders Insomnia	16.4% 10/61 • Number of events 17 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	15.6% 5/32 • Number of events 11 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Psychiatric disorders Personality change	3.3% 2/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Psychiatric disorders Psychosis	0.00% 0/61 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Renal and urinary disorders Glomerular filtration rate decreased	1.6% 1/61 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Renal and urinary disorders Hemorrhage urinary tract	3.3% 2/61 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Renal and urinary disorders Protein urine positive	3.3% 2/61 • Number of events 7 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Renal and urinary disorders Urinary frequency	4.9% 3/61 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Renal and urinary disorders Urinary incontinence	3.3% 2/61 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Renal and urinary disorders Urinary retention	3.3% 2/61 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Renal and urinary disorders Urogenital disorder	0.00% 0/61 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	9.8% 6/61 • Number of events 15 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	6.2% 2/32 • Number of events 7 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	3.3% 2/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Bronchospasm	4.9% 3/61 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Cough	32.8% 20/61 • Number of events 40 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	28.1% 9/32 • Number of events 23 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Dyspnea	27.9% 17/61 • Number of events 34 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	21.9% 7/32 • Number of events 15 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Hemorrhage nasal	8.2% 5/61 • Number of events 6 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	6.2% 2/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Hiccough	0.00% 0/61 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Hypoxia	4.9% 3/61 • Number of events 10 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.9% 3/61 • Number of events 4 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	1.6% 1/61 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.3% 2/61 • Number of events 5 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Pulmonary hemorrhage	3.3% 2/61 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	6.6% 4/61 • Number of events 6 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Respiratory tract hemorrhage	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Respiratory, thoracic and mediastinal disorders Voice alteration	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Skin and subcutaneous tissue disorders Alopecia	31.1% 19/61 • Number of events 57 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	31.2% 10/32 • Number of events 32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Skin and subcutaneous tissue disorders Decubitus ulcer	3.3% 2/61 • Number of events 8 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Skin and subcutaneous tissue disorders Nail disorder	1.6% 1/61 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Skin and subcutaneous tissue disorders Pruritus	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Skin and subcutaneous tissue disorders Rash desquamating	11.5% 7/61 • Number of events 11 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	21.9% 7/32 • Number of events 10 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Skin and subcutaneous tissue disorders Scalp pain	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Skin and subcutaneous tissue disorders Skin disorder	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/61 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Skin and subcutaneous tissue disorders Skin hypopigmentation	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Skin and subcutaneous tissue disorders Skin ulceration	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Skin and subcutaneous tissue disorders Sweating	4.9% 3/61 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Vascular disorders Hematoma	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Vascular disorders Hot flashes	1.6% 1/61 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Vascular disorders Hypertension	3.3% 2/61 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	0.00% 0/32 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Vascular disorders Hypotension	9.8% 6/61 • Number of events 10 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	9.4% 3/32 • Number of events 5 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Vascular disorders Phlebitis	1.6% 1/61 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 2 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Vascular disorders Thrombosis	1.6% 1/61 • Number of events 3 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.
Vascular disorders Vasculitis	0.00% 0/61 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.	3.1% 1/32 • Number of events 1 "Other" adverse events include all grades and attributions to treatment not included in the "Serious" adverse events table.

Additional Information

DCC Project Administrator

California Cancer Consortium

Phone: 626-256-4673

Email: CCCP@coh.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60