Trial Outcomes & Findings for Paclitaxel, Nab-paclitaxel, or Ixabepilone With or Without Bevacizumab in Treating Patients With Stage IIIC or Stage IV Breast Cancer (NCT NCT00785291)

NCT ID: NCT00785291

Last Updated: 2022-10-10

Results Overview

Progression-free survival (PFS) is defined as the interval from registration until first disease progression, regardless of site, or death resulting from any cause, which ever occurred first. Distribution was estimated using the Kaplan Meier product-limit method. Progression is defined as a 20% increase in the sum of longest diameter of target lesions (per Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 799 participants
• Primary outcome timeframe: Time from randomization to progression or death due to any cause, whichever occurs first (up to 5 years)
• Results posted on: 2022-10-10

Participant Flow

Between October 2008 - November 2011, a total of 799 participants were recruited.

Participant milestones

Measure	Arm A (Paclitaxel) Patients receive 90 mg/m\^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.	Arm B (Nab-paclitaxel) Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.	Arm C (Ixabepilone) Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
Overall Study STARTED	283	271	245
Overall Study COMPLETED	147	122	139
Overall Study NOT COMPLETED	136	149	106

Reasons for withdrawal

Measure	Arm A (Paclitaxel) Patients receive 90 mg/m\^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.	Arm B (Nab-paclitaxel) Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.	Arm C (Ixabepilone) Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
Overall Study Never began treatment	8	4	4
Overall Study Adverse Event	39	70	56
Overall Study Death	7	4	3
Overall Study Withdrawal by Subject	35	36	17
Overall Study Alternative Therapy	12	6	7
Overall Study Complicating illness	6	4	4
Overall Study Other Medical Reasons	29	25	15

Baseline Characteristics

Paclitaxel, Nab-paclitaxel, or Ixabepilone With or Without Bevacizumab in Treating Patients With Stage IIIC or Stage IV Breast Cancer

Baseline characteristics by cohort

Measure	Arm A (Paclitaxel) n=283 Participants Patients receive 90 mg/m\^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.	Arm B (Nab-paclitaxel) n=271 Participants Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.	Arm C (Ixabepilone) n=245 Participants Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)	Total n=799 Participants Total of all reporting groups
Age, Customized 20-29	2 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	5 participants n=4 Participants
Age, Customized 30-39	15 participants n=5 Participants	18 participants n=7 Participants	17 participants n=5 Participants	50 participants n=4 Participants
Age, Customized 40-49	52 participants n=5 Participants	56 participants n=7 Participants	55 participants n=5 Participants	163 participants n=4 Participants
Age, Customized 50-59	109 participants n=5 Participants	89 participants n=7 Participants	86 participants n=5 Participants	284 participants n=4 Participants
Age, Customized 60-69	74 participants n=5 Participants	74 participants n=7 Participants	68 participants n=5 Participants	216 participants n=4 Participants
Age, Customized 70-79	24 participants n=5 Participants	28 participants n=7 Participants	15 participants n=5 Participants	67 participants n=4 Participants
Age, Customized 80+	7 participants n=5 Participants	4 participants n=7 Participants	3 participants n=5 Participants	14 participants n=4 Participants
Sex: Female, Male Female	277 Participants n=5 Participants	268 Participants n=7 Participants	243 Participants n=5 Participants	788 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=5 Participants	15 Participants n=7 Participants	13 Participants n=5 Participants	47 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	252 Participants n=5 Participants	239 Participants n=7 Participants	221 Participants n=5 Participants	712 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants	17 Participants n=7 Participants	11 Participants n=5 Participants	40 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Black or African American	42 Participants n=5 Participants	45 Participants n=7 Participants	26 Participants n=5 Participants	113 Participants n=4 Participants
Race (NIH/OMB) White	220 Participants n=5 Participants	214 Participants n=7 Participants	206 Participants n=5 Participants	640 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants	10 Participants n=7 Participants	8 Participants n=5 Participants	33 Participants n=4 Participants
Region of Enrollment United States	283 participants n=5 Participants	271 participants n=7 Participants	245 participants n=5 Participants	799 participants n=4 Participants
Prior Adjuvant Taxane Yes	125 participants n=5 Participants	120 participants n=7 Participants	107 participants n=5 Participants	352 participants n=4 Participants
Prior Adjuvant Taxane No	158 participants n=5 Participants	151 participants n=7 Participants	138 participants n=5 Participants	447 participants n=4 Participants
Hormone Receptor Status ER/PgR Positive	201 participants n=5 Participants	195 participants n=7 Participants	178 participants n=5 Participants	574 participants n=4 Participants
Hormone Receptor Status ER/PgR Negative	82 participants n=5 Participants	76 participants n=7 Participants	67 participants n=5 Participants	225 participants n=4 Participants
Physician's Decision to use Bevacizumab Bevacizumab planned	51 participants n=5 Participants	44 participants n=7 Participants	15 participants n=5 Participants	110 participants n=4 Participants
Physician's Decision to use Bevacizumab Bevacizumab not planned	8 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants	20 participants n=4 Participants
Physician's Decision to use Bevacizumab Bevacizumab required	224 participants n=5 Participants	223 participants n=7 Participants	222 participants n=5 Participants	669 participants n=4 Participants

PRIMARY outcome

Timeframe: Time from randomization to progression or death due to any cause, whichever occurs first (up to 5 years)

Population: Participants who never began protocol treatment were excluded.

Progression-free survival (PFS) is defined as the interval from registration until first disease progression, regardless of site, or death resulting from any cause, which ever occurred first. Distribution was estimated using the Kaplan Meier product-limit method. Progression is defined as a 20% increase in the sum of longest diameter of target lesions (per Response Evaluation Criteria in Solid Tumors [RECIST] criteria).

Outcome measures

Measure	Arm A (Paclitaxel) n=275 Participants Patients receive 90 mg/m\^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.	Arm B (Nab-paclitaxel) n=267 Participants Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.	Arm C (Ixabepilone) n=241 Participants Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
Progression Free Survival	10.97 months Interval 9.79 to 12.42	9.3 months Interval 8.15 to 10.45	7.36 months Interval 6.21 to 8.18

SECONDARY outcome

Timeframe: Up to 5 years

Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions).

Outcome measures

Measure	Arm A (Paclitaxel) n=275 Participants Patients receive 90 mg/m\^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.	Arm B (Nab-paclitaxel) n=267 Participants Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.	Arm C (Ixabepilone) n=241 Participants Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
Objective Tumor Response Rate	38.2 percentage of participants	34.1 percentage of participants	25.6 percentage of participants

SECONDARY outcome

Timeframe: Time from randomization until progression, death, or yearly termination of protocol therapy (up to 5 years)

Population: Participants who never began protocol treatment were excluded.

Time from registration until treatment failure, defined as early termination of protocol therapy for any reason, first disease progression or death without progression. Surviving participants who were failure free were censored as date last known alive and failure free. Distribution was estimated using the Kaplan Meier product-limit method.

Outcome measures

Measure	Arm A (Paclitaxel) n=275 Participants Patients receive 90 mg/m\^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.	Arm B (Nab-paclitaxel) n=267 Participants Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.	Arm C (Ixabepilone) n=241 Participants Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
Time to Treatment Failure	6.6 months Interval 5.62 to 7.2	5.19 months Interval 4.83 to 5.55	4.93 months Interval 4.21 to 5.29

SECONDARY outcome

Timeframe: 12 months

Population: Participants who never began protocol treatment were excluded.

Percentage of participants who were alive and progression free at 12 months. The 12 month progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.

Outcome measures

Measure	Arm A (Paclitaxel) n=275 Participants Patients receive 90 mg/m\^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.	Arm B (Nab-paclitaxel) n=267 Participants Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.	Arm C (Ixabepilone) n=241 Participants Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
12 Month Progression Free Survival	45 percentage of participants Interval 39.0 to 51.0	36 percentage of participants Interval 30.0 to 42.0	28 percentage of participants Interval 23.0 to 35.0

SECONDARY outcome

Timeframe: Time from randomization to death or last follow-up (up to 5 years)

Overall survival was measured as the interval from study entry until death, from any cause, or last contact. Distribution was estimated using the Kaplan Meier product-limit method.

Outcome measures

Measure	Arm A (Paclitaxel) n=275 Participants Patients receive 90 mg/m\^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.	Arm B (Nab-paclitaxel) n=267 Participants Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.	Arm C (Ixabepilone) n=241 Participants Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
Overall Survival	26.55 months Interval 23.8 to 32.9	23.52 months Interval 20.4 to 28.2	23.53 months Interval 19.9 to 25.6

Adverse Events

Arm A (Paclitaxel)

Serious events: 65 serious events

Other events: 263 other events

Deaths: 0 deaths

Arm B (Nab-paclitaxel)

Serious events: 80 serious events

Other events: 248 other events

Deaths: 0 deaths

Arm C (Ixabepilone)

Serious events: 59 serious events

Other events: 230 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm A (Paclitaxel) n=272 participants at risk Patients receive 90 mg/m\^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.	Arm B (Nab-paclitaxel) n=264 participants at risk Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.	Arm C (Ixabepilone) n=238 participants at risk Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
Blood and lymphatic system disorders Blood disorder	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Blood and lymphatic system disorders Bone marrow hypocellular	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Blood and lymphatic system disorders Febrile neutropenia	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Blood and lymphatic system disorders Hemoglobin decreased	5.1% 14/272 • Number of events 17 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	6.8% 18/264 • Number of events 22 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	5.0% 12/238 • Number of events 14 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Blood and lymphatic system disorders Lymphatic disorder	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Cardiac disorders Atrial fibrillation	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Cardiac disorders Atrial tachycardia	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Cardiac disorders Left ventricular dysfunction	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.5% 4/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Cardiac disorders Left ventricular failure	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.7% 4/238 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Cardiac disorders Myocardial ischemia	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Cardiac disorders Palpitations	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Cardiac disorders Pericardial effusion	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Cardiac disorders Restrictive cardiomyopathy	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Cardiac disorders Sinus tachycardia	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Cardiac disorders Stokes-Adams syndrome	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Cardiac disorders Supraventricular tachycardia	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Endocrine disorders Cushingoid	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Endocrine disorders Hypothyroidism	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Eye disorders Dry eye syndrome	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Eye disorders Eye pain	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Eye disorders Retinopathy	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Eye disorders Vision blurred	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Eye disorders Watering eyes	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Abdominal distension	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Abdominal pain	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.7% 4/238 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Ascites	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Cecum perforation	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Colitis	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Colonic obstruction	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Colonic perforation	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.9% 5/264 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Constipation	1.8% 5/272 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.3% 6/264 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.8% 9/238 • Number of events 10 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Diarrhea	2.6% 7/272 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.2% 11/264 • Number of events 12 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.6% 11/238 • Number of events 12 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Dry mouth	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Duodenal hemorrhage	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Duodenal perforation	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Duodenal ulcer	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Dyspepsia	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Fecal incontinence	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Gastric hemorrhage	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Gastrointestinal disorder	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Gingival pain	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Hemorrhoidal hemorrhage	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Hemorrhoids	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Ileus	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Intra-abdominal hemorrhage	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Mucositis oral	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.3% 6/264 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Nausea	2.2% 6/272 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	7.2% 19/264 • Number of events 21 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	8.8% 21/238 • Number of events 24 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Oral hemorrhage	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Oral pain	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Small intestinal perforation	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Stomach pain	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Toothache	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Vomiting	2.2% 6/272 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.5% 12/264 • Number of events 14 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	6.3% 15/238 • Number of events 16 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
General disorders Chest pain	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.3% 3/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
General disorders Chills	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
General disorders Death NOS	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
General disorders Disease progression	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
General disorders Edema limbs	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.3% 3/238 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
General disorders Fatigue	15.8% 43/272 • Number of events 56 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	21.2% 56/264 • Number of events 64 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	16.8% 40/238 • Number of events 44 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
General disorders Fever	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.7% 7/264 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
General disorders General symptom	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
General disorders Localized edema	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
General disorders Multi-organ failure	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
General disorders Pain	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Hepatobiliary disorders Cholecystitis	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Hepatobiliary disorders Hepatic failure	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Hepatobiliary disorders Hepatobiliary disease	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Immune system disorders Cytokine release syndrome	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Immune system disorders Hypersensitivity	1.1% 3/272 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Abdominal infection	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Anorectal infection	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Biliary tract infection	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Bladder infection	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Catheter related infection	1.8% 5/272 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.5% 4/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.3% 3/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Colitis, infectious (e.g., Clostridium difficile)	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Device related infection	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Encephalitis infection	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Eye infection	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Gallbladder infection	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Infection	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.7% 4/238 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Infection without neutropenia	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Infectious colitis	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Kidney infection	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Mucosal infection	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Opportunistic infection	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Peritoneal infection	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Pneumonia	1.5% 4/272 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.9% 5/264 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.9% 7/238 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Salivary gland infection	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Sepsis	1.1% 3/272 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.5% 4/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Sinusitis	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Skin infection	1.8% 5/272 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.5% 4/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Soft tissue infection	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Tooth infection	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Upper respiratory infection	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Urinary tract infection	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.3% 6/264 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.1% 5/238 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Uterine infection	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Vulvitis	0.37% 1/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Wound infection	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Injury, poisoning and procedural complications Fracture	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.3% 3/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Injury, poisoning and procedural complications Injury to carotid artery	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Injury, poisoning and procedural complications Intraoperative gastrointestinal injury - Teeth	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Injury, poisoning and procedural complications Wound dehiscence	0.74% 2/272 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations ADH abnormal	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Activated partial thromboplastin time prolonged	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Alanine aminotransferase increased	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Alkaline phosphatase increased	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.3% 3/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Aspartate aminotransferase increased	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.5% 4/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.5% 6/238 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Blood bilirubin increased	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Creatinine increased	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.3% 3/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations INR increased	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Laboratory test abnormal	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Leukocyte count decreased	2.6% 7/272 • Number of events 8 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	6.4% 17/264 • Number of events 19 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.9% 7/238 • Number of events 9 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Lymphocyte count decreased	1.1% 3/272 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.5% 6/238 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Neutrophil count decreased	5.9% 16/272 • Number of events 19 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	13.6% 36/264 • Number of events 39 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	5.9% 14/238 • Number of events 16 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Platelet count decreased	1.1% 3/272 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.9% 13/264 • Number of events 13 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.2% 10/238 • Number of events 10 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Weight gain	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Weight loss	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.9% 5/264 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.7% 4/238 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Anorexia	2.2% 6/272 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.8% 10/264 • Number of events 12 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.9% 7/238 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Blood bicarbonate decreased	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Blood glucose increased	2.2% 6/272 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.0% 8/264 • Number of events 9 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.4% 8/238 • Number of events 10 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Blood uric acid increased	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Dehydration	1.1% 3/272 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.4% 9/264 • Number of events 10 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.6% 11/238 • Number of events 12 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Serum albumin decreased	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.4% 9/264 • Number of events 10 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.5% 6/238 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Serum calcium decreased	1.5% 4/272 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.0% 8/264 • Number of events 9 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.7% 4/238 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Serum magnesium decreased	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Serum phosphate decreased	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Serum potassium decreased	1.8% 5/272 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.9% 5/264 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.8% 9/238 • Number of events 9 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Serum potassium increased	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Serum sodium decreased	1.1% 3/272 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.0% 8/264 • Number of events 9 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.9% 7/238 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Serum sodium increased	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Arthralgia	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.9% 5/264 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.1% 5/238 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Back pain	1.5% 4/272 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.0% 8/264 • Number of events 10 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.1% 5/238 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Bone pain	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.1% 5/238 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Chest wall pain	1.5% 4/272 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Joint disorder	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Muscle weakness	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.5% 4/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.7% 4/238 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.37% 1/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Myalgia	2.9% 8/272 • Number of events 10 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.5% 12/264 • Number of events 13 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.2% 10/238 • Number of events 10 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Osteonecrosis	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Pain in extremity	1.1% 3/272 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Ataxia	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Cognitive disturbance	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Depressed level of consciousness	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Dizziness	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.3% 3/238 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Dysgeusia	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Headache	1.5% 4/272 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.9% 5/264 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.1% 5/238 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Intracranial hemorrhage	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Ischemia cerebrovascular	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Leukoencephalopathy	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Mini mental status examination abnormal	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Neuralgia	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Neurological disorder NOS	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Peripheral motor neuropathy	1.8% 5/272 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.8% 10/264 • Number of events 11 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.4% 8/238 • Number of events 8 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Peripheral sensory neuropathy	12.9% 35/272 • Number of events 45 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	16.3% 43/264 • Number of events 50 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	13.4% 32/238 • Number of events 38 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Seizure	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Speech disorder	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Syncope	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Psychiatric disorders Anxiety	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Psychiatric disorders Confusion	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.5% 4/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.3% 3/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Psychiatric disorders Depression	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Psychiatric disorders Insomnia	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Glomerular filtration rate decreased	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Hemoglobin urine positive	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Hemorrhage urinary tract	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Proteinuria	2.9% 8/272 • Number of events 9 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.8% 10/264 • Number of events 10 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.9% 7/238 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Renal failure	1.1% 3/272 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Ureteric fistula	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Ureteric obstruction	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Urinary incontinence	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Urogenital disorder	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Reproductive system and breast disorders Pelvic pain	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Reproductive system and breast disorders Perineal pain	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Cough	2.2% 6/272 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.5% 4/264 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.3% 3/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Dyspnea	4.4% 12/272 • Number of events 12 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.9% 13/264 • Number of events 15 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	6.3% 15/238 • Number of events 17 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.8% 9/238 • Number of events 9 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Hypoxia	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.5% 4/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.3% 3/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Laryngoscopy abnormal	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.5% 4/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.5% 4/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.3% 3/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Voice alteration	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Alopecia	1.5% 4/272 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.7% 7/264 • Number of events 9 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.5% 6/238 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Hand-and-foot syndrome	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Pain of skin	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Pruritus	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Rash desquamating	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Skin ulceration	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Sweating	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Urticaria	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Vascular disorders Hemorrhage	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Vascular disorders Hypertension	5.5% 15/272 • Number of events 17 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	6.4% 17/264 • Number of events 17 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	7.1% 17/238 • Number of events 17 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Vascular disorders Hypotension	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.5% 4/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.7% 4/238 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Vascular disorders Lymphedema	0.74% 2/272 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Vascular disorders Phlebitis	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Vascular disorders Thrombosis	2.6% 7/272 • Number of events 9 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.7% 7/264 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.7% 4/238 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Vascular disorders Vascular disorder	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)

Other adverse events

Measure	Arm A (Paclitaxel) n=272 participants at risk Patients receive 90 mg/m\^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.	Arm B (Nab-paclitaxel) n=264 participants at risk Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.	Arm C (Ixabepilone) n=238 participants at risk Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
Blood and lymphatic system disorders Anemia	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Blood and lymphatic system disorders Blood disorder	0.37% 1/272 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Blood and lymphatic system disorders Bone marrow hypocellular	1.1% 3/272 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Blood and lymphatic system disorders Febrile neutropenia	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Blood and lymphatic system disorders Hemoglobin decreased	18.0% 49/272 • Number of events 202 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	18.6% 49/264 • Number of events 165 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	16.8% 40/238 • Number of events 128 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Blood and lymphatic system disorders Lymph node pain	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Blood and lymphatic system disorders Lymphatic disorder	0.37% 1/272 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Cardiac disorders Atrial fibrillation	0.37% 1/272 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Cardiac disorders Atrial tachycardia	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Cardiac disorders Cardiac disorder	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Cardiac disorders Cardiac pain	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Cardiac disorders Edema	1.1% 3/272 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Cardiac disorders Left ventricular dysfunction	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Cardiac disorders Left ventricular failure	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Cardiac disorders Myocardial ischemia	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Cardiac disorders Palpitations	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Cardiac disorders Pericardial effusion	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Cardiac disorders Sinus bradycardia	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Cardiac disorders Sinus tachycardia	1.1% 3/272 • Number of events 20 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.3% 3/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Cardiac disorders Supraventricular tachycardia	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Ear and labyrinth disorders Ear disorder	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Ear and labyrinth disorders Ear pain	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Ear and labyrinth disorders Hearing impaired	0.37% 1/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Ear and labyrinth disorders Tinnitus	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.3% 3/238 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Endocrine disorders Cushingoid	0.37% 1/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Eye disorders Cataract	0.74% 2/272 • Number of events 28 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Eye disorders Diplopia	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Eye disorders Dry eye syndrome	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.3% 3/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Eye disorders Eye disorder	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.5% 4/264 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Eye disorders Flashing vision	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Eye disorders Optic nerve disorder	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Eye disorders Photophobia	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Eye disorders Vision blurred	1.5% 4/272 • Number of events 12 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.9% 13/264 • Number of events 31 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Eye disorders Vitreous hemorrhage	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Eye disorders Watering eyes	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.4% 9/264 • Number of events 19 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Abdominal distension	0.74% 2/272 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Abdominal pain	3.3% 9/272 • Number of events 13 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.7% 7/264 • Number of events 10 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.2% 10/238 • Number of events 12 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Anal fistula	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Anal hemorrhage	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Anal pain	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Ascites	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Cheilitis	0.37% 1/272 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Colitis	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Colonic hemorrhage	0.37% 1/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Constipation	12.9% 35/272 • Number of events 84 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	13.6% 36/264 • Number of events 95 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	18.9% 45/238 • Number of events 87 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Diarrhea	12.9% 35/272 • Number of events 74 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	13.6% 36/264 • Number of events 67 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	18.9% 45/238 • Number of events 85 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Dry mouth	1.1% 3/272 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.7% 4/238 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Dyspepsia	4.0% 11/272 • Number of events 20 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.9% 13/264 • Number of events 19 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	8.4% 20/238 • Number of events 34 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Dysphagia	1.5% 4/272 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Ear, nose and throat examination abnormal	1.1% 3/272 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.9% 5/264 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.1% 5/238 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Esophagitis	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Flatulence	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Gastric ulcer	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Gastritis	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Gastrointestinal disorder	1.8% 5/272 • Number of events 11 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.3% 3/238 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Gastroscopy abnormal	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Gingival pain	0.74% 2/272 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Hemorrhoidal hemorrhage	1.1% 3/272 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Hemorrhoids	1.1% 3/272 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.4% 8/238 • Number of events 15 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Mucositis oral	7.7% 21/272 • Number of events 35 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	8.3% 22/264 • Number of events 40 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	6.7% 16/238 • Number of events 32 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Nausea	17.6% 48/272 • Number of events 92 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	19.7% 52/264 • Number of events 123 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	31.5% 75/238 • Number of events 160 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Oral hemorrhage	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.5% 4/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.1% 5/238 • Number of events 9 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Oral pain	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.5% 4/264 • Number of events 10 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Pancreatitis	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Periodontal disease	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 11 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Peritoneal pain	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Proctitis	0.37% 1/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Rectal bleeding/hematochezia	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Rectal hemorrhage	3.3% 9/272 • Number of events 24 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.0% 8/264 • Number of events 11 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.1% 5/238 • Number of events 8 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Rectal pain	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Stomach pain	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Tooth development disorder	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Tooth disorder	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Toothache	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Gastrointestinal disorders Vomiting	6.6% 18/272 • Number of events 24 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	10.2% 27/264 • Number of events 45 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	12.2% 29/238 • Number of events 48 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
General disorders Chest pain	2.2% 6/272 • Number of events 11 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.3% 3/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
General disorders Chills	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.5% 4/264 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.7% 4/238 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
General disorders Edema limbs	4.0% 11/272 • Number of events 37 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.9% 13/264 • Number of events 37 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.6% 11/238 • Number of events 46 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
General disorders Facial pain	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
General disorders Fatigue	76.5% 208/272 • Number of events 1397 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	80.7% 213/264 • Number of events 1186 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	86.1% 205/238 • Number of events 1036 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
General disorders Fever	1.5% 4/272 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.9% 5/264 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.9% 7/238 • Number of events 14 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
General disorders Flu-like symptoms	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
General disorders Gait abnormal	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
General disorders General symptom	0.37% 1/272 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
General disorders Ill-defined disorder	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
General disorders Injection site reaction	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.3% 3/238 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
General disorders Localized edema	1.5% 4/272 • Number of events 13 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
General disorders Pain	7.7% 21/272 • Number of events 34 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.9% 13/264 • Number of events 16 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	5.0% 12/238 • Number of events 24 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Hepatobiliary disorders Gallbladder obstruction	0.37% 1/272 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Hepatobiliary disorders Hepatic failure	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Hepatobiliary disorders Hepatic pain	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Immune system disorders Hypersensitivity	8.5% 23/272 • Number of events 32 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	10.6% 28/264 • Number of events 48 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	7.1% 17/238 • Number of events 19 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Immune system disorders Immune system disorder	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Bladder infection	1.1% 3/272 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Bronchitis	1.1% 3/272 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Catheter related infection	1.5% 4/272 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Colitis, infectious (e.g., Clostridium difficile)	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Conjunctivitis infective	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Device related infection	0.74% 2/272 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Esophageal infection	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Eye infection	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Gingival infection	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Infection	2.9% 8/272 • Number of events 9 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.3% 6/264 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Infection with grade 3 or 4 neutropenia	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Infection without neutropenia	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Infectious colitis	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Kidney infection	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Laryngitis	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Mucosal infection	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Nail infection	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Otitis media	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Paranasal sinus infection	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Peripheral nerve infection	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Pneumonia	1.5% 4/272 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Rhinitis infective	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Salivary gland infection	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Sepsis	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Sinusitis	2.2% 6/272 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.3% 6/264 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.3% 3/238 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Skin infection	1.5% 4/272 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Small intestine infection	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Soft tissue infection	0.37% 1/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Tooth infection	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Upper aerodigestive tract infection	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Upper respiratory infection	1.8% 5/272 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.5% 4/264 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.5% 6/238 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Ureteritis	0.37% 1/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Urinary tract infection	3.3% 9/272 • Number of events 12 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.3% 6/264 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.8% 9/238 • Number of events 14 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Vaginal infection	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Vulvitis	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Infections and infestations Wound infection	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Injury, poisoning and procedural complications Bruising	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.5% 4/264 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Injury, poisoning and procedural complications Dermatitis radiation	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Injury, poisoning and procedural complications Fracture	1.1% 3/272 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Injury, poisoning and procedural complications Intraoperative breast injury	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Injury, poisoning and procedural complications Seroma	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Injury, poisoning and procedural complications Wound dehiscence	3.7% 10/272 • Number of events 28 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.8% 10/264 • Number of events 32 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.8% 9/238 • Number of events 15 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Alanine aminotransferase increased	5.1% 14/272 • Number of events 18 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	6.8% 18/264 • Number of events 28 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	7.6% 18/238 • Number of events 35 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Alkaline phosphatase	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Alkaline phosphatase increased	4.0% 11/272 • Number of events 31 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.2% 11/264 • Number of events 27 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	7.6% 18/238 • Number of events 31 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Aspartate aminotransferase increased	5.5% 15/272 • Number of events 21 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	6.8% 18/264 • Number of events 31 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	7.1% 17/238 • Number of events 39 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Blood bilirubin increased	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.7% 4/238 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Creatinine increased	3.3% 9/272 • Number of events 16 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.5% 4/264 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 14 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Electrocardiogram QTc interval prolonged	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Gamma-glutamyltransferase increased	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations INR increased	0.74% 2/272 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Laboratory test abnormal	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.5% 6/238 • Number of events 9 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Leukocyte count decreased	20.2% 55/272 • Number of events 188 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	33.0% 87/264 • Number of events 242 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	17.2% 41/238 • Number of events 98 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Lymphocyte count decreased	2.6% 7/272 • Number of events 26 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.8% 10/264 • Number of events 27 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.1% 5/238 • Number of events 13 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Neutrophil count decreased	42.6% 116/272 • Number of events 447 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	67.4% 178/264 • Number of events 650 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	26.9% 64/238 • Number of events 144 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Platelet count decreased	8.5% 23/272 • Number of events 50 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	10.6% 28/264 • Number of events 65 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	6.7% 16/238 • Number of events 44 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Serum cholesterol increased	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Weight gain	1.1% 3/272 • Number of events 9 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.3% 3/238 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Investigations Weight loss	4.0% 11/272 • Number of events 19 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.9% 13/264 • Number of events 35 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	5.9% 14/238 • Number of events 31 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Anorexia	8.8% 24/272 • Number of events 50 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	9.5% 25/264 • Number of events 48 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	12.6% 30/238 • Number of events 61 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Blood bicarbonate decreased	0.37% 1/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Blood glucose increased	11.8% 32/272 • Number of events 129 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	11.0% 29/264 • Number of events 64 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	12.2% 29/238 • Number of events 64 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Dehydration	2.2% 6/272 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.7% 7/264 • Number of events 9 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.5% 6/238 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Serum albumin decreased	3.7% 10/272 • Number of events 17 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.0% 8/264 • Number of events 19 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.6% 11/238 • Number of events 23 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Serum calcium decreased	3.3% 9/272 • Number of events 18 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.0% 8/264 • Number of events 12 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.2% 10/238 • Number of events 16 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Serum calcium increased	1.1% 3/272 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Serum glucose decreased	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Serum magnesium decreased	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Serum magnesium increased	0.37% 1/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Serum phosphate decreased	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Serum potassium decreased	4.0% 11/272 • Number of events 21 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.4% 9/264 • Number of events 15 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	5.0% 12/238 • Number of events 21 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Serum potassium increased	1.5% 4/272 • Number of events 15 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Serum sodium decreased	4.0% 11/272 • Number of events 33 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.8% 10/264 • Number of events 19 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	5.9% 14/238 • Number of events 25 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Serum sodium increased	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Metabolism and nutrition disorders Serum triglycerides increased	1.1% 3/272 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Arthralgia	15.4% 42/272 • Number of events 122 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	14.4% 38/264 • Number of events 75 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	15.5% 37/238 • Number of events 117 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Arthritis	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Back pain	5.9% 16/272 • Number of events 28 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.5% 12/264 • Number of events 33 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	10.9% 26/238 • Number of events 51 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Bone pain	7.4% 20/272 • Number of events 41 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.2% 11/264 • Number of events 21 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	5.5% 13/238 • Number of events 30 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Buttock pain	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Chest wall pain	1.5% 4/272 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Fibrosis	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Joint range of motion decreased cervical spine	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Muscle weakness	0.74% 2/272 • Number of events 9 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.4% 9/264 • Number of events 19 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.3% 3/238 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	1.1% 3/272 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	1.1% 3/272 • Number of events 9 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.7% 4/238 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Myalgia	33.8% 92/272 • Number of events 336 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	37.5% 99/264 • Number of events 295 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	32.4% 77/238 • Number of events 210 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Neck pain	2.2% 6/272 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.3% 3/238 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Osteonecrosis	1.1% 3/272 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Osteoporosis	0.37% 1/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Musculoskeletal and connective tissue disorders Pain in extremity	6.2% 17/272 • Number of events 27 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.4% 9/264 • Number of events 12 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.6% 11/238 • Number of events 21 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Ataxia	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Cognitive disturbance	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Depressed level of consciousness	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Dizziness	4.8% 13/272 • Number of events 20 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.2% 11/264 • Number of events 14 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	6.3% 15/238 • Number of events 27 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Dysgeusia	4.4% 12/272 • Number of events 61 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	5.7% 15/264 • Number of events 40 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	12.2% 29/238 • Number of events 59 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Encephalopathy	0.37% 1/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Extrapyramidal disorder	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Headache	7.4% 20/272 • Number of events 28 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	8.3% 22/264 • Number of events 43 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	12.6% 30/238 • Number of events 50 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Intracranial hemorrhage	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Ischemia cerebrovascular	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Memory impairment	0.74% 2/272 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Mini mental status examination abnormal	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Neuralgia	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.3% 3/238 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Neurological disorder NOS	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Peripheral motor neuropathy	16.9% 46/272 • Number of events 110 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	25.0% 66/264 • Number of events 208 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	19.7% 47/238 • Number of events 204 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Peripheral sensory neuropathy	79.4% 216/272 • Number of events 1533 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	78.0% 206/264 • Number of events 1320 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	73.5% 175/238 • Number of events 1043 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Radiculitis brachial	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Seizure	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Speech disorder	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Syncope	1.8% 5/272 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.7% 4/238 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Syncope vasovagal	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Nervous system disorders Tremor	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Psychiatric disorders Agitation	0.74% 2/272 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Psychiatric disorders Anxiety	5.9% 16/272 • Number of events 29 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.7% 7/264 • Number of events 11 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.2% 10/238 • Number of events 19 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Psychiatric disorders Confusion	0.74% 2/272 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Psychiatric disorders Depression	4.8% 13/272 • Number of events 33 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	5.3% 14/264 • Number of events 20 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	5.9% 14/238 • Number of events 33 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Psychiatric disorders Euphoria	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Psychiatric disorders Insomnia	6.6% 18/272 • Number of events 41 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.9% 13/264 • Number of events 25 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	8.0% 19/238 • Number of events 35 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Psychiatric disorders Libido decreased	0.37% 1/272 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 8 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Psychiatric disorders Psychosis	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Bladder hemorrhage	0.74% 2/272 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Bladder pain	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Cystitis	1.1% 3/272 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Glomerular filtration rate decreased	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Hematuria (in the absence of vaginal bleeding)	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Hemoglobin urine positive	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Hemorrhage urinary tract	1.1% 3/272 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Kidney pain	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Proteinuria	21.3% 58/272 • Number of events 211 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	24.2% 64/264 • Number of events 188 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	21.0% 50/238 • Number of events 125 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Ureteric hemorrhage	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Ureteric obstruction	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Ureteric stenosis	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Urethral hemorrhage	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Urethral pain	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Urinary frequency	1.5% 4/272 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Urinary incontinence	1.8% 5/272 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Urinary retention	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Renal and urinary disorders Urogenital disorder	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Reproductive system and breast disorders Breast pain	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Reproductive system and breast disorders Irregular menstruation	0.74% 2/272 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Reproductive system and breast disorders Ovulation pain	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Reproductive system and breast disorders Pelvic pain	1.1% 3/272 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Reproductive system and breast disorders Perineal pain	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Reproductive system and breast disorders Vaginal discharge	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Reproductive system and breast disorders Vaginal dryness	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Reproductive system and breast disorders Vaginal hemorrhage	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.9% 5/264 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Reproductive system and breast disorders Vaginal pain	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	2.9% 8/272 • Number of events 14 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.7% 7/264 • Number of events 10 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	5.9% 14/238 • Number of events 22 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 5 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Cough	9.6% 26/272 • Number of events 65 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	7.6% 20/264 • Number of events 43 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	10.1% 24/238 • Number of events 54 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Dyspnea	9.9% 27/272 • Number of events 62 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	11.0% 29/264 • Number of events 61 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	15.1% 36/238 • Number of events 91 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Epistaxis	25.0% 68/272 • Number of events 174 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	21.2% 56/264 • Number of events 185 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	19.7% 47/238 • Number of events 112 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 9 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Laryngeal mucositis	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Laryngoscopy abnormal	1.8% 5/272 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.4% 9/264 • Number of events 19 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.1% 5/238 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.8% 5/272 • Number of events 9 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.9% 5/264 • Number of events 9 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.1% 5/238 • Number of events 12 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.9% 5/264 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.7% 4/238 • Number of events 9 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Pulmonary hemorrhage	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Respiratory disorder	1.5% 4/272 • Number of events 10 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.7% 7/264 • Number of events 9 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.5% 6/238 • Number of events 8 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Respiratory tract hemorrhage	1.1% 3/272 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Tracheal fistula	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Respiratory, thoracic and mediastinal disorders Voice alteration	1.8% 5/272 • Number of events 11 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.5% 6/238 • Number of events 14 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Alopecia	12.9% 35/272 • Number of events 151 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	9.8% 26/264 • Number of events 65 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	16.8% 40/238 • Number of events 116 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Chest wall necrosis	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Decubitus ulcer	1.1% 3/272 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Dry skin	1.1% 3/272 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.5% 4/264 • Number of events 7 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.9% 7/238 • Number of events 10 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Erythema multiforme	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Hand-and-foot syndrome	1.8% 5/272 • Number of events 16 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.7% 7/264 • Number of events 15 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Nail disorder	11.8% 32/272 • Number of events 96 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	9.1% 24/264 • Number of events 63 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	6.7% 16/238 • Number of events 28 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Pain of skin	0.37% 1/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Petechiae	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.38% 1/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Photosensitivity	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Pruritus	2.9% 8/272 • Number of events 9 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.0% 8/264 • Number of events 19 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.7% 4/238 • Number of events 17 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Rash acneiform	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.7% 7/264 • Number of events 11 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.3% 3/238 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Rash desquamating	6.2% 17/272 • Number of events 28 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	12.9% 34/264 • Number of events 71 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	5.9% 14/238 • Number of events 33 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Scalp pain	0.74% 2/272 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Skin disorder	4.0% 11/272 • Number of events 17 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.9% 5/264 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Skin hyperpigmentation	1.1% 3/272 • Number of events 15 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.5% 4/264 • Number of events 10 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Skin ulceration	1.1% 3/272 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Sweating	1.1% 3/272 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 8 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Skin and subcutaneous tissue disorders Urticaria	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Vascular disorders Flushing	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.76% 2/264 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Vascular disorders Hematoma	0.74% 2/272 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Vascular disorders Hemorrhage	1.1% 3/272 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.1% 3/264 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.84% 2/238 • Number of events 2 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Vascular disorders Hot flashes	1.8% 5/272 • Number of events 15 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.4% 9/264 • Number of events 12 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	4.2% 10/238 • Number of events 25 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Vascular disorders Hypertension	46.7% 127/272 • Number of events 596 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	36.7% 97/264 • Number of events 418 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	37.8% 90/238 • Number of events 345 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Vascular disorders Hypotension	0.37% 1/272 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.5% 4/264 • Number of events 4 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	2.1% 5/238 • Number of events 6 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Vascular disorders Lymphedema	0.00% 0/272 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.42% 1/238 • Number of events 1 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Vascular disorders Phlebitis	0.37% 1/272 • Number of events 18 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/264 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	0.00% 0/238 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
Vascular disorders Thrombosis	2.6% 7/272 • Number of events 30 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	3.0% 8/264 • Number of events 13 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)	1.3% 3/238 • Number of events 3 Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)

Additional Information

Hope Rugo, M.D.

UCSF Comprehensive Cancer Center

Email: hrugo@medicine.ucsf.edu

Results disclosure agreements

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

Restriction type: LTE60